Pfizer

I received the COVID-19 Vaccination in 12-29-2020. As time went on, I felt a little flushed , Lightheaded , some dizziness that night. Forced the water intake. 12-30-2020, went to work, as the day went on the rash on my face and neck into upper chest increased and Hypertension. I went to the ER Dept at Hospital. IV Fluids and IV Benadryl and oral Prednisone and Prednisone to be taken at home. Face and neck rash goes away and comes back as of Jan 1 2021.

Patient was discharged at 1:25 came back at 1:36 with itchy rash on forearm, given Benadryl 50mg IM. Assessed by doctor working clinic at 2:15, rash was fading and itching resolved. No breathing or airway issues, was discharged.

No symptoms or pain with initial injection. I came home about 2 hours after the injection and took one 200mg ibuprofen and one 500mg acetaminophen and put an ice pack on the site briefly. Later that afternoon I developed pain at the injection site that progressively got worse over the course of the evening so bad that I could not raise my left arm of touch the site. I put an ice pack on again and that night I slept with a heating pad on. I would rate the pain 8/10. When I woke the next day the pain was still there, but not as severe. I got in the shower and let the hot water beat on the injection site and that seems to help a lot. The pain gradually lessened over the course of the day to a 2/10. By the following day (3rd day post injection) the pain had completely subsided. There was no redness or swelling at the site and I did not have any other symptoms other than the intense injection site pain.

* Had sore arm at the vaccine site * Headache began at 7 pm on 3-Jan * Had chills during the night, cold and unable to get warm even with multiple blankets * Severe dizziness and vomiting * Headache not relieved by Ibuprofen; took 25 mg Benadryl at midnight

12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.

Immediately after injection into patient's left deltoid, site swelling and felt firm. Some bruising noted. Ice applied and patient monitored for over 30 minutes. Patient did complain of scratchy throat while being monitored, but refused Benadryl at this time. Patient will notify her physician of this reaction to the vaccine.

Red, itchy rash to both upper and lower extremities and upper back. Started 1/01/2021 to present. Treated with prednisone 60 mg x 5 days and trimcinolon 0.025% topically

Rhinorrhea; Fever; Injection site pain; Chills; facial flushing; This is a spontaneous report from a non-contactable other-HCP (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231) (Brand= Pfizer), via an unspecified route of administration on 24Dec2020 07:15AM at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The facility type vaccine was workplace clinic. None medical history. The patient's concomitant medications was not reported. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The known allergies included Ibuprofen based pain medicine. On 24Dec2020, patient experienced injection site pain; chills; facial flushing. 25Dec2020 fever. 26Dec2020 rhinorrhea. Patient didn't receive treatment for the adverse events. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was recovered in Dec2020. No follow-up attempts are possible. No further information is expected.

Some swelling of arm; Rash developed 5cm x 4cm at injection site; Chills and shivers; Bronchospasm cough; Bronchospasm cough; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Mild eczema flare ups, itchiness and sores; Spasm; she has a lot of allergies; This is a spontaneous report from a contactable nurse. This 60-year-old female nurse (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 to 23Dec2020 at 0.3 mL single on left deltoid to prevent getting the COVID vaccine, for protection. Medical history included ongoing asthma diagnosed in her mid twenties, in the 80s, she had asthma when she was a child, then it stopped and resurfaced in her mid twenties, ongoing eczema diagnosed years already, a long time ago and unspecified allergies with medications. There were no concomitant medications. She received the vaccine on 23Dec2020. She has a lot of allergies in Dec2020, and had some side effects, and she got through it ok. Her side effects were some swelling of arm, a rash developed, like 5cm x 4cm at site of injection, chills and shivers, and a bronchospasm cough on 24Dec2020. Arm swelling event started 24 hours later, no more, it was stable for 24 hours, and the 3rd day, went down, was a little raised, the next day was flat but still red. She had recovered completely. The 4th day was a good day. The patient stated she had some allergy shots she had to go through before, this was no different. Rash was no more, it was gone by 27Dec2020. She was still able to go to work. Chills and shivers started 24 hours later, and took for 48 hours intermittently, she had since recovered completely. The patient stated this was all nothing different than getting like the flu shot. Bronchospasm cough event only took another 48 hours, the difference was, even when she calls it bronchospasm, it was close to when she had an asthma attack, but no chest tightness, shortness of breath, she just would cough, spasm in Dec2020 and stop. She had recovered completely. The patient stated she had no symptoms at all before the vaccine, she was healthy, she made sure nothing was going on, that she was not tired, had no cold, she took no medications for this, as she wanted to know how her body reacted and if it can handle it. They says it was ok to take paracetamol (TYLENOL), but she did not, but the second dose she would, now that she knows and she was comfortable through it. She did have some mild eczema flare ups, itchiness and sores that came up in Dec2020, but nothing to run to the hospital to the doctor for. Clarifies this occured after she received the vaccine. The outcome of the event allergies, mild eczema flare ups, itchiness and sores were unknown. The outcome of rash at site of injection was recovered on 27Dec2020. The outcome of other events was recovered in Dec2020. The causality between Pfizer COVID vaccine with some swelling of arm, rash developed 5cm x 4cm at injection site, chills and shivers, bronchospasm cough was related (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection). Information on the lot/batch number has been requested.

Felt mildly fluish by end of working shift (1130 pm), arm became more sore, unable to lay on it in bed. Woke up in middle of night with body aches , chills and headache. By 10 am felt increase in flu like symptoms, mild nausea, swollen glands, mouth cold sore and red hot face. Temp was 101.2. All joints hurt, general malaise.

Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; This is a spontaneous report from a contactable other-HCP (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included pulmonary embolism and known allergies: penicillin. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), tocopherol (VITAMIN E), received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine administered was in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 14:45, the patient experienced golf ball size swelling below the injection site. Arm was red and itchy. No treatment received for the adverse event. Outcome of the events was recovering. This report was assessed as non-serious. Information about Lot/batch number has been requested.

INJECTION SITE REDNESS, NAUSEA, FEELING UNWELL, HEADACHE, FAST HEART BEAT, SLIGHT ITCHING, DIZZINESS, TIREDNESS, MUSCLE PAIN, CHILLS ALL BY 13:30PM AND LASTED FROM 1.04.21 AND CURRENTLY ON 1.06.21 STILL TIRED, DIZZY, HEADACHE, CHILLS AND ITCHY BUT IS BETTER THAN ON 1.04.21.

Itching but no hives; dizziness; slight headache; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (Batch/lot number: EK5730) intramuscular at Left arm, on 31Dec2020 at single dose for covid-19 immunisation. Medical history included mild Hypertension (HTN), Hypothyroidism, Anxiety, Gastrooesophageal reflux disease (GERD), Hyperlipidemia. Known allergies included Shellfish, SSRI, Demerol, Codeine. The patient did not have covid prior vaccination. Patient had no other vaccine in four weeks. Concomitant medication included lisinopril, levothyroxine, aluminium hydroxide gel, dried, magnesium carbonate (PEPCID), bupropion hydrochloride (WELLBUTRIN), atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN), vitamin c [ascorbic acid], calcium, linum usitatissimum seed oil (FLAX SEED OIL), glucosamine, curcuma longa (TURMERIC), ubidecarenone (COQ 10), collagen. The patient experienced itching but no hives, slight headache, dizziness on 31Dec2020 15:30. The patient received Benadryl 25mg for the events. The patient did not have covid tested post vaccination. The outcome of events was recovering.

hand was swollen and itchy on the same arm where the injection was; back of hand was swollen and itchy on the same arm where the injection was; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via an unspecified route of administration (Deltoid Right) from 26Dec2020 15:00 at single dose for Covid-19 immunization. The patient's medical history included chronic pain and insomnia. Concomitant medications included hydrocodone and temazepam. The patient reported, "On 26Dec2020 I got my first immunization for COVID and today (30Dec2020) I woke up and the back of my hand was swollen and itchy on the same arm where the injection was". The patient further stated "It never have happened before I don't have any reaction at the injection site but it was kind of odd that it kind of showed up on the back of my hand, it feels like an allergy kind of thing." The patient tried the Voltaren Gel to try and get the inflammation down, but it didn't help, and she took some Benadryl it doesn't seem to help much. The patient's next shot is due on "12Jan2021". The outcome of events was unknown.

30-40 min felt flush skin on body face bright red. Numbness tingling in hands and feet. Took some advil. Over next two days on and off hot flashes tingling numbness on hands and feet. Very cold feet couldn't get warmed up till wrapped up on heating pad. Ño fever but felt chills. Sore arm site of injection.

APPROXIMATELY 24 HOURS AFTER THE INJECTIONS I RAN A FEVER OF 100.7, BODY ACHES OVER ALL JOINTS, EXTREME FATIGUE AND HEADACHE ADN THE INJECTION SITE WAS PAINFUL. I HAD THE COVID VIRUS DIAGNOSED 10/23/2020 WITH THE EXACT SAME SYMPTOMS EXCEPT I RAN A HIGHER TEMP

Received 2nd dose at 10:30 am at Hospital. I went to work as usual at 1:45 pm though 10:00 pm. without any issues. Came home, had 2 glasses of wine, as usual, at 1:00 a.m. feeling body aches and headache continued sleeping, woke up at 9:00 a.m. with dry heaves with phlegm with small streaks of blood, rapid heart rate, fatigue with body aches, pain in location of injection, occasional headache, loss of appetite. The body aches, fatigue continued the following day, appetite returned slightly. Thankful these were my scheduled days off from work. Third day after injection body aches dissipating able to go out of the house to do errands.

intensely pruritic rash, starting around neck initially and then presenting in perianal area, moving up lower back with sharp linear demarcations, also perinasal bilat . Also on eyelid with periorbital edema rt>lt. Typical appearance of contact derm with raised indurated intensely pruritic lesion except almost exact opposite in distribution (flexoral/internal aspects of skin) and no known exposures. Now day two and rash is becoming more well demarcated, more red and inflamed and spreading in distribution face, neck and lower back. There is no logical explanation for this rash.

Sudden onset nausea; Swelling at injection site.; abdominal cramps; single episode loose stool; This is a spontaneous report from a contactable nurse, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL0140), via an unspecified route of administration on 30Dec2020 at 09:15 (at the age of 60-years-old) as a single dose, in the right arm for COVID-19 vaccination. Medical history included lymphedema, lipedema, depression, osteoporosis, osteoarthritis, hypothyroid, malabsortion with vitamin deficiencies, anemia, and allergy to latex. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, however it was reported the patient received other medications (unspecified) within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took thimerisol and influenza vaccine both from unknown dates to unknown dates for unknown indications and experienced allergy. On 30Dec2020 at 10:00, the patient experienced sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site. The patient did not receive any treatment for the events. The clinical outcome of the events sudden onset nausea, abdominal cramps, single episode loose stool, and swelling at injection site was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

arm was sore; she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach; inherited some type of reaction like a rash, its itchy; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1685, Expiry Date: Mar2021, via an unspecified route of administration on left arm from 29Dec2020 to 29Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypertension (verbatim: Blood Pressure High), thyroid disorder (verbatim: Thyroid), cholesterol. The patient's concomitant medications were not reported. The patient stated she got her vaccination on 29Dec2020, that's Tuesday and her arm was sore the next day (30Dec2020) but she have inherited some type of reaction like a rash, its itchy, her hands are itching like crazy, she has like underneath her neck, underneath her armpits, underneath her breast, on her stomach that's not so itchy it's the hands that's itchy. The patient was asking what should she do. The outcome of the events was unknown. When asked for treatment for the events, the patient stated, "I was doing some, I take an Aleve, Aspirin and then I was taking some Benadryl capsule for allergy."

chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

very dizzy/ felt like her Blood pressure dropped/she felt like she was going to faint; she felt really really sick/ didn't feel good/felt very bad; Sweating; Nauseous; loose stool; her injection site had a lump and was red; a little pain in her arm/ it was just a little sore; her injection site had a lump and was red; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 11:30 at single dose in the arm for COVID-19 immunization. There were no relevant medical history and no concomitant medications. The patient received the vaccine 29Dec2020 at 11:30 am. She went to work at 11 at night and only had a little pain in her arm. At 4 am on 30Dec2020, she felt really sick. She felt like her blood pressure dropped. She was very dizzy. She was scared. She didn't feel good. She felt like she was going to faint and was sweating. She was going to try to finish her work and go home. She went to the house, and was very sick. She got into bed because she believed she needed rest. At 3 pm on 30Dec2020, nothing was wrong. She was going to rest more. That night time on 30Dec2020, she felt better. She had also got nauseous. She stated the symptoms only lasted a day, and also said the side effects only lasted from 4 o'clock to 8 o'clock when she got home. She did go to the bathroom and experienced loose stool. She felt very bad when she laid down in bed. By 10 o'clock pm (30Dec2020) she felt better. The patient said she had no problem moving her arm as it was just a little sore. When she got home from work her husband noticed her injection site had a lump and was red. Her arm recovered in a week's time. The patient stated she would go for her second shot on 13Jan2021. The symptoms which started on 30Dec2020 04:00 (dizzy/felt like her blood pressure dropped/she felt like she was going to faint, feeling sick/bad, sweating, nauseous, loose stool) were resolved on 30Dec2020. The events pain in her arm and injection site lump and red were resolved on an unspecified date in Jan2021. Information about lot and batch number was requested.

Approximately 24 hrs after injectio rash occurred to groin area & lower abdomen. Then appeared in multiple patchy areas. Over next 10 days rash appeared on right of mid sternum, right upper ribs, coccyx area, nap of neck. Rash was small red bumps any extremely pruritic

Had initial vaccine on 12/21/2020. Broke out in rash reported in a previous report file. After 2nd injection, at some of the exact locations of healing rash from 1st, new eruptions of red raised pruritic rash occurred. Lower abdomen, top of right ribs and nape of neck.

c/o itching and pressure in her head. Narrative: c/o of itching and pressure in head. Staff gave Diphenhydramine HCL VS 178/85, 72, 18, 98% O2sat. at 1340 states she felt better.

1/1/2021: soreness at site 01/08/2021: headache,malaise 01/09/2021: redness & inflammation, hot to touch, swelling 3" x 3", small raised blisters. 01/11/2021: symptoms are subsiding; pink, warm to touch, swelling 2" x 2", blisters fading

On the 3rd day after the injection I felt a burning sensation on the skin of my neck then with in 10 minutes the feeling spread over my whole body. Not an itch just a burning and slight red patches on my: Neck, upper back and inner side of my arms. It wasn't like a hot flash I was expecting hive welts but that didn't happen.

Patient reported soreness/painful up into clavicle area of right side where injection occurred. Patient also reports swollen and painful lymph nodes on right side where injection occurred.

Pain at injection site; Tiredness; Headache; Chills; Joint pain; Fever; Felt paralyzed at one point; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: K5730, via an unspecified route of administration from 29Dec2020 16:15 at a SINGLE DOSE for covid-19 immunization. Medical history included migraine with aura. Concomitant medication included gabapentin, pravastatin, estradiol, diphenhydramine hydrochloride (ALLERGY), and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took amoxicillin and had allergies. On 30Dec2020 15:00, the patient experienced pain at injection site, tiredness, chills, joint pain, fever and felt paralyzed at one point. The outcome of events was recovering. No follow-up attempts possible. No further information expected.

Patient developed a rash on her neck beginning on the right side and continued to increase around her neck. She is still experiencing redness today. She also has some itching of her scalp. She did not require intervention.

Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.

Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.

Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.

Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.

4 days after receiving Covid shot in left arm, shingles appeared on right scapula area, 3 days later shingles appeared on right upper lateral arm form shoulder to forearm

Patient received her first dose of COVID-19 vaccine at 9:27 am. Around 9:40, the patient complained of head tingling and body itchiness.

10 minutes after receiving vaccine pt. c/o severe itching on face and neck. No hives, shortness of breath or distress noted. Pt. declined to take Benadryl or Epinephrine - requested to go to hospital for evaluation.

About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99%, RR 17, HR 68). no wheezing, SOB, swelling, chest pain, dizziness, abd pain, NV. about 15 minutes later, lip tingling improved but began c/o generalized urticaria with mild erythema to left upper chest. patient well appearing at that time, A&Ox3, no increased WOB, SOB, hives, facial swelling, facial redness. Patient reports she experienced same urticaria about 24-48 hours after 1st COVID vaccine dose, treated at home with po benadryl with improvement. Placed on continuous monitoring and administered 25 mg Benadryl po with improvement in symptoms. About 30 min after benadryl administration symptoms resolved. Offered ER evaluation to which patient declined. She works within hospital and agrees to seek emergency medical care should symptoms return or worsen. can continue to take benadryl at home and monitor closely.

Employee reported chills, muscle aches, headache, pain at injection site, fatigue, nausea, pruritus, and pressure on her upper back. She reported feeling anxious when she laid down. She went to see her doctor last week and was treated with benadryl.

I got the vaccine in the AM and I was fine all day just a little itchy in the morning. Around 2AM in the morning I had high fever, chills, and a very bad headache, and shooting pain like a shock in legs and arms (I had the same when had covid around 04/2020 and was out of work until June 2020 - I developed double pneumonia). It lasted until 11AM the next day. Got a covid test around noon and it was negative and on the 25th I started feeling better. Got second dose on 01/13/2021 had the same symptoms but not as severe.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

Soreness at injection site x 48 hours--no treatment Slight twitching in left eyelid x 48 hours--no treatment--still have a little twitching in the eye but seems to be getting better

I received the Pfizer COVID-19 vaccine on 1/7/21 which resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On Friday, 01/15/21 a couple hours after exercising (elliptical and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up Saturday, 01/16/21, the redness, soreness, and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to Urgent Care, which I did and was prescribed Doxycycline for possible cellulitis. Today, 01/18/21, sx's have much improved.

patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.

6PM DAY OF SHOT ITCHING IN EXTREMITIES LOWER LEGS AND ARMS JUST ABOVE WRIST. PAINFUL LOWER BACK PAIN. TOOK TWO BENEDRYL AND SYMPTOMS RESOLVED BY AM. 1/16 HAD SYMPTOMS OF AN ON-COMING COLD, SLIGHT SORE THROUGH, SINUS PRESSURE AND FELT WARM. NO TREATMENT OTHER THAN FLUIDS AND REST AND RESOLVED BY MORNING. 1/17 AND 1/18 ONLY SYMPTOM MILD FATIGUE

began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face

Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching

1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums

Injection site got really red started about a quarter in diameter and swelled to about 9 inches in diameter. Itched and was painful. Lasted about 1 weeks time. Ibuprofen and diphenhydramine.

taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

INJECTION 1===back ache, heat from waist down to top of knees, no fever INJECTION 2===rash on top of both legs- no fever

12 hours after injection uncontrollable shaking with chills, severe headache and body aches. Hours later turned into sweating/heat. Mild upset stomach throughout. Soreness/brusing at injection site. After 18 hours headache persisted with mild body aches and upset stomach. Still soreness /brusing at injection site. 24 hours after injection very mild backache. No headache. Soreness at injection site. No other issues.

7 hours after the injection, I broke out in hives in my torso. Over the next 2 days, it has spread to my whole body. I am taking Benadryl to try to relieve the itching.

BRUISING, IT STARTED ON LEFT THIGH AND WENT TO LOWER LFT ABDOMEN WITH FIRST INJECTION. AFTER 2ND INJECTION IT WENT TO THE RIGHT THIGH AND HAD SMALL BRUISES.

Chills (freezing), aches and pain all over, headache, felt feverish with no fever, painful arm at site of injection with swelling- took total of 4 tylenol over a course of 20 hours- symptoms lasted about 20 hours- arm swelling and pain lasted about 3 days

I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

1 hour after vaccine -itchy injection site and small rash starting on top of left arm, took 50mg of Benadryl 1 hour after Benadryl- rash was spreading to the whole arm , neck and intermittent labored breathing started patient was taken to hospital and received 2 doses of epinephrine and nebulizer treatment

25 minutes status post the vaccine patient experienced head itchiness. Patient was brought to the triage room and had fine rash on chest. BP noted to be 190/90, HR 60, RR 16, sat 100%, and no SOB/difficulty breathing. Allergy on call was paged and patient was given zyrtec. After given zyrtec patient was monitored for two hours. There was a redness on patient's neck which was continually lessened, HR, RR, and sat remained stable throughout. Sat remained between 150-170 for the next hour. After 2 hours the redness on neck has completely resolved and BP 153/79. Allergist on call notified. Plan was to have patient go to ER if she experienced SOB, chest pain, or headache.

Bumpy red rashes in arms and legs; Shortness of breath; Mild chest pain; Severe dizziness; Congestion; This is a spontaneous report from a contactable healthcare professional (patient). A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown, vaccine location: right arm), intramuscular on 04Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included hypertension/high blood pressure controlled, GERD/acid reflux, fast heart rate, and prediabetic. Concomitant medications included losartan, metoprolol, gemfibrozil (LOPID), aspirin [acetylsalicylic acid], atorvastatin, vitamin D3, zinc, magnesium, ascorbic acid (VIT C), vitamin B complex (VIT B COMPLEX), alpha-d-galactosidase (BEANO), angelica keiskei leaf, sambucus nigra extract (SAMBUCOL), and unspecified stress supplement. The patient is not pregnant. The patient received a flu shot administered on the right arm on 28Oct2020 and pneumo vacc administered on the left arm on 28Oct2020. The patient received no other vaccine in four weeks. The patient had no COVID-19 prior to vaccination. The patient was tested for COVID-19 post vaccination (test type: nasal swab, test name: COVID PCR) on 22Dec2020 with result negative. On 04Jan2021 13:15, the patient experienced bumpy red rashes in arms and legs, shortness of breath, mild chest pain, severe dizziness, and congestion. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was recovering. Information about lot/batch number has been requested.

Received Pfizer vaccine on January 7 at approximately 5:20PM. This morning on January 13 at 5:20 AM, I noticed a rash on my left upper arm/deltoid at the vaccine site. Rash is flat and red, approximately 8 cm x 8 cm, but not circular.

Slight fever, 99.2, with chills and muscle aches. Event occurred about 2:00 am on 01/26/2021. I took a Tylenol went back to bed. No fever upon waking. Minor muscle aches and mild soreness at injection site.

Very swollen and erythematous arm; Very swollen and erythematous arm; chills; severe neck pain; myalgias; This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient (not pregnant) received first dose of bnt162b2 (Lot number: Ek5730), via an unspecified route of administration in left arm on 22Dec2020 11:30 at single dose for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing (COVID prior vaccination: Yes). There were no concomitant medications. The patient experienced very swollen and erythematous arm, chills, severe neck pain, myalgias, all on 22Dec2020 14:00. The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No treatment given. The outcome of events was resolved. Facility type vaccine: Hospital. No other vaccine in four weeks. No other medications in two weeks. No COVID tested post vaccination. Not known allergies or other medical history.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

RASH STARTED 2 DAYS AFTER VACCINE ON MY WRISTS, AND SLOWLY WENT UP MY ARMS BY SUNDAY MORNING. BY MONDAY MORNING RASH WAS ON MY LEGS, CHEST, BACK AND ARMS. ITCHY, RED AND RAISED WELTS IN PLACES. JUST UNCOMFORTABLE. IT'S NOW WEDNESDAY AND IT'S SLOWLY GOING AWAY, STILL RED AND ITCHY. I DID NOT GO TO MY PCP. I DID SHOW MY RASH TO MY INFECTIOUS DISEASE PHYSICIAN AT OUR HOSPITAL. I HAVE BEEN TAKING AN ANTIHISTAMINE THAT HAS HELPED.

There are two events I am reporting, one each from the first dose on 12/19/20, and the second dose on 1/9/21: Approximately 53 hours after Dose #1: Redness on hands and wrist, rash-like small dot appearance on hands and wrists, skin dryness and tightness of hands. I experienced no itching of hands or wrists. Approximately 53 hours after Dose #2: Small, painful red pustule-like occurrence on base of right thumb, with the appearance of a few small dots in it. I experienced no itching of thumb or hand. These events both occurred within the same timeframe following the vaccine doses. Following the first event I was seen in the ER. I checked out fine and they could not say exactly what this was. They said it did not appear to be an allergic reaction to the vaccine because it was not systemic and I had no other symptoms such as trouble breathing. They thought perhaps it was coincidental...I work in the hospital as a radiologic technologist where I hand-wash and hand-sanitize all day. Perhaps I just over-washed that day? However I've worked there for 17 years and never had this happen. The redness and rash dissipated by end of day. Following the second event I did not follow up with any medical provider. This pustule I got happened while I was at home, and otherwise I felt fine so I left it at that. It took several days for the pustule to go away. I hope you don't mind but I am writing to report this information in the event it may be helpful to you and I am also reporting it because I want to know if what I experienced could be considered an immune response to the vaccine? Another words, not an allergic response but an immune response ? I can find absolutely nothing about this on-line and no one knows what to make of it. Thank you.

like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Had normal site pain, fatigue and began running fever of about 100.0 the evening of injection however the fever has continued x7 days, getting as high as 101.9. I began noticing soreness in the lymph nodes in my neck and underarms on the evening of 1/25 and that lasted until midmorning of 1/27.

Rash across face, part of her cheeks over her nose; Arm sore; Received two vaccine within 10 minutes of each other and now to be re-vaccinated again the second dose; not enough research can guarantee if that's safe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140, expiry:Mar2021), intramuscular on 12Jan2021 at a SINGLE DOSE then intramuscular on 12Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol increased, fistula, surgery on 18Dec2020. It was stated, "Sure, I am hoping you can help me. I am one of the legal guardians for our younger sister who has special needs. She is residing in a group home, group home in the city area she is currently been out of it because she has surgery. They have made arrangements for them to still ask for them to receive the first Pfizer Covid 19 Vaccination just this past Tuesday so I go from up there from my home in city and we had a problem in there they screwed up and ended up vaccinating her twice within 10 minutes. I asked the pharmacist, there I asked the RN what does that mean for her I mean I didn't know what that meant but normally we would sat for 15 minutes, they made her sat for 30 minutes. The nurse was there from the group home monitored her blood pressure and temperature and then we got in the car proceeded to drive 3 and half hour. They said just watch for temperature, labored breathing, take her to the emergency room call 911, the only thing she did have about an hour after she broke out that was "malar" (not clarified) rash across her face part of her cheeks over her nose that lasted for about 30 minutes. The next day her arm was sore which was going to happen but here is my question though she received two vaccine within 10 minutes of each other and now they are wanting her to be re-vaccinated again which would have been the second dose, supposedly on 02Feb2021. Nobody can tell me if that's safe or if that's okay, they can't guarantee, they all kept telling me, the nurse says, I called the pharmacist kept saying there's not been enough research to know if it's safe for her to get that next vaccine, so I don't know what to do." The reporter also stated, "IM, Both went for IM, first one went into her left arm and second shot was given in her right arm." The patient underwent lab tests and procedures which included blood pressure measurement: unknown result on an unspecified date, blood test: unknown result on 05Jan2021, body temperature: unknown result on an unspecified date, sars-cov-2 test: unknown results pre-surgery and post-surgery. The outcome of the event rash across face, part of her cheeks over her nose was recovered and arm sore was unknown.

tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing her tooth; right arm being sore started after 1.5 hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for covid-19 (immunization). There were no medical history and concomitant medications. Patient had got her Pfizer Covid vaccine on 13Jan2021 and thought she had a reaction and wanted to know if anyone had this reaction. On 14Jan2021, patient stated on right side where got shot on that her tongue on the side was bruised. She stated that her arm hurt last night. She stated this was her first dose. She later clarified that it was her right arm. Patient stated that it was a big black spot that she noticed this morning while brushing her tooth (14Jan2021). Her right arm being sore started after 1.5 hours after the shot (13Jan2021). No treatments received in response to the events reported. The events "tongue on the side was bruised" and "it was a big black spot that she noticed this morning while brushing her tooth" were not recovered. The outcome of the event "right arm being sore started after 1.5 hours after the shot" was recovered on 14Jan2021.

I received the vaccine at approximately 8:10 a.m. Approximately 12 hours post-injection, I began to feel malaise and fatigue. Upon waking around midnight, I had developed a 102.4 degree (F) fever, total body ache, headache, chills, and cough. Most symptoms lasted approximately 24 hours. The headache, although now mild, persists into the third day. On the third morning following the injection, I woke to find a slightly painful triangular-shaped red, raised patch on the same arm as the injection (left). The "rash" measures approximately 4.5 cm x 7 cm.

Moderate Swelling and pain under right axilla Redness swelling at site Nausea Aches Abdominal pain Headache

itchy, swollen soft pallet, need to cough started approx. 15 mins after vaccine given and continued and plateaued for hour and half. Benadryl and prednisone given in ED. Monitored and D/C with no further progression of sx.

6 hours after vaccination: vaccination sight soreness and swelling - still have this symptom 3 days later 12 hrs after vaccination: Nausea, vomiting, headache, body aches, fever (100.7 at peak), chills. Lasted approximately 36 hours. 48 hours after vaccination: vaccinated arm has tingling sensation and weakness when raised, armpit lymph nodes tendor/sore - still have this symptom 3 days later. Took Aleve to alleviate symptoms. It lessened them somewhat but I was still not able to function fully for several days.

Patient received their first dose of Pfizer vaccine on 1.27.2021. Patient reports little red spots that are itchy on their legs, thighs, and chest that started the day after receiving the vaccine. The patient states that they are NOT experiencing any facial swelling, scratchy/itchy throat/ShOB. Patient states the rash has improved with over the counter medications. Encouraged the patient to reach out to provider with any more worrisome or bothersome conditions, including worsening of rash. Reviewed when the patient should seek emergency care.

Developed chills, a low grade fever and headache on same day of her vaccination. The next day, she developed an itchy rash on her left arm which became panful. She saw her PCP who diagnosed shingles.

Dizziness and nausea within 7 minutes of receiving vaccine. 6 Hours after vaccine severe arm pain, sensitive to touch, movement and unable to lift arm beyond 45 degree angle. 17 hours after vaccine chills, fever of 102, muscle aches, severe headache, fatigue. 53 hours after vaccine, fever 101, severe headache, muscle aches, fatigue. Arm pain much less severe.

FEVER FOR ABOUT 24 HOURS, HEADACHE FOR ABOUT 24 HOURS AND LEFT ARM RED AND WARM TO TOUCH FOR 36 HOURS

Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones. I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29. There was the normal injection site soreness on the evening of the first day.

Rash raised, red, warm, and itchy in area covering about 7 cm underneath injection site. This started on Feb. 2. Also had fever of 100 degrees, body aches, headache for about 36 hours, it started 12 hours after I received the vaccine.

headache, joint & bone pain, red lump at injection site, injection site warm to the touch, soreness at injection site, some wheezing 40 x 40 mm

noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; noticed 3 lumps the size of finder tip on her shoulder that were red and itchy; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EK9231) at single dose on left arm on 03Jan2021 at 0830AM for COVID-19 immunisation. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Medical history was none. Family medical history was none. Relevant test was none. Prior Vaccinations (within 4 weeks) was none. There was no concomitant medication. Patient received 1st dose on 03Jan2021. Yesterday (18Jan2021), she noticed 3 lumps the size of finder tip on her shoulder that were red and itchy. Across her cleavage, she noticed another 3-4 lumps. She noticed last night, 18Jan2021, three lumps on her shoulder that were really itchy and red and three or four across her cleavage area but not as large. She was just checking, she knew it said could have swollen lymph glands. Patient mentioned she tried to set the phone thing set up where they call you but she could not do it. The shoulder lumps were on her left side and about the size of tip of her little finger. She tried Witch Hazel; she rubbed it on and that soothed it a little at that time. she was scheduled for the second dose of the vaccine on the 25Jan2021. Patient asked if this was normal and what could the end result possibly be. The adverse events did not require a visit to physician or ER. The outcome of events was not resolved.

slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; slight redness and soreness at the site/at the site of vaccination was redness, soreness, and heat; at the site of vaccination was redness, soreness, and heat; possible cellulitis; This is a spontaneous report from a contactable other HCP. A 60-years-old female patient receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 07Jan2021 16:45 at single dose (lot number: EK4176) for covid-19 immunisation. Medical history included hypertension (HTN), anxiety, arthritis, seasonal allergy, known allergies: Penicillin, Sulfa, Bactrim. No covid prior vaccination. Concomitant medication included losartan, citalopram, cetirizine. The patient experienced vaccine resulted in slight redness and soreness at the site. This gradually dissipated over a few days, but not completely. On 15Jan2021 a couple hours after exercising (elliptical use and hand weights) at the site of vaccination was redness, soreness, and heat. Upon waking up 16Jan2021, the redness, soreness and heat had increased - area was 6cm x 7cm - contacted pcp and was advised to go to (urgent care withheld) which she did and was prescribed Doxycycline for possible cellulitis. Today 18Jan2021, redness, soreness, and heat have much improved. Treatment received for the events. Events resulted in physician office/clinic visit. Outcome of events was recovering.

Developed Itching and feeling of tightness in back of nose/throat. Advised employee to go to ED. Was given 1L fluid, Solu-Medrol and Benadryl. No swelling of airways was observed and no respiratory distress noted. ED discharged patient to home.

minor local injection site pain , SOB, palpitation, chest tightness. 1/14 sx started and she reported to job 1/15. She had hard time to ambulate wearing a facemask. 1/17 sx fully resolved.

At 2:30 pm after being in observation for 30 minutes, patient became concerned about a rash to her left arm. There was a small area that had a lace modeling appearance. Patient denied any pain or itchiness to this area and there were no hives. Patient very anxious and concerned and asked if she could take her own liquid Benadryl which she had on hand. She was offered Benadryl from the clinic but refused and really wanted to take her own. Approval from supervisor obtained and Benadryl was verified. VS BP 110/60, HR 76 and pulse ox 98% at 2:35 pm. Patient denied any other signs and symptoms of allergic reaction except anxiety. VS repeated at 2:55pm and were; BP 110/60, HR 68, Pulse ox 100%. No change in condition and patient felt good enough to leave. Patients sister accompanied her to the clinic today and will stay with her tonight.

admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.

Nothing major. A weeping painful welt to the right of injection site started overnight on the day of injection. Did not report Subsided several days later

Developed rash at back. Resolved spontaneously at one week post vaccination. Vaccine #2 given 3 weeks later @ 2/7/21. Rash reported when patient came in for Pfizer vaccine #2 (after resolved). Did not report to healthcare system or present to medical care for evaluation.

Pt had vaccine at about 1pm, did well, went back to work. At 2pm, pt came back to say she was itching all over arms, back hands, scalp. BP 138/62, gave one diphenhydramine 25mg po. At 2:15-- same symptoms, no worsening. At 2:30pm, per pt less itchy; NO n/v; NO thickening feel of tongue/throat; pt will take Allegra at 6pm; will notify Dr/ER if any worsening of symptoms

injection site pain; chills; muscle aches; fatigue; Rash on torso, arms; This is a spontaneous report from a non-contactable other hcp (patient). A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Jan2021 14:30 at single dose in Left arm for covid-19 immunisation. The patient was not Pregnant at the time of vaccination. Medical history was none. Concomitant drug received within 2 weeks of vaccination included Multivitamin. The patient previously received first dose of BNT162B2 on 29Dec2020 03:15 PM at single dose in Left arm for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 6 hrs on 19Jan2021 21:00 PM, the patient experienced injection site pain. After 12 hrs the patient experienced chills, muscle aches, fatigue in Jan2021. The patient experienced Rash on torso, arms 36 hours after in Jan2021. The outcome was Recovering. No treatment received for events. The events were assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible, information about batch number cannot be obtained.

The symptoms began 10 minutes after administration of the vaccine. The symptoms were: anxiety and globus sensation pale and tremulous. Nurse noted that she had a 4mm hive above her lip. The treatment of the reaction was: o Epinephrine: x1 Transferred to ED

her face got swollen; lymph node right there it was extremely swollen and very tender and very painful; She had a lump at the site of the injection; chills; headache; flu like symptoms; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EL8982) vaccine , via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation . Medical history included hypertension. Concomitant medication included telmisartan (MICARDIS). On 30Dec2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced her face got swollen on an unspecified date with outcome of unknown , lymph node right there it was extremely swollen and very tender and very painful on an unspecified date with outcome of unknown , she had a lump at the site of the injection on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown , headache on an unspecified date with outcome of unknown , flu like symptoms on an unspecified date with outcome of unknown. The events swollen face and lymph adenopathy were considered important medical Events. The remaining events were considered non serious. The patient stated she got the second vaccine shot of Pfizer on Wednesday the 20Jan2021. She got like a weird side effect like under her armpit it got really swollen and painful, like the lymph node right there it was extremely swollen and very tender and very painful. It still is but not as much. The next day the right side of her face was swollen The patient received Tylenol as treatment for the events. Follow up information has been requested.

left upper arm redness and swelling. She reports she got the second Pfizer COVID-19 vaccine on Monday 2/1. She reports the area is red right after the vaccine. She reports she has had increased swelling, redness, warmth. She reports she did have reaction to her first vaccine with redness and swelling, but that occurred 10 days after. She reports she has had some fever and body aches that she associates with having the second vaccine. Constitutional: Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Negative for cough and shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal pain, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for joint swelling and arthralgias. Negative for back pain. Skin: Positive for color change. Negative for rash. Neurological: Negative for weakness and numbness.

fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.

positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot# EL3249, exp.date May2021 on 15Jan2021 16:00 at single dose for COVID-19 immunization, via unspecified route of administration at the left arm. The patient had get earlier in January a DPT (diphtheria, pertussis, and tetanus) vaccine in the left arm. The patient had have a Pneumonia and Shingles vaccines in the last 2 years and she had no problems in past with vaccines, but stated she did get a little bit of swelling and had to put heat to the area with vaccines, but never had a fever afterwards. The patient had not medical history. Concomitant medications were not reported. No other vaccines given the same day. Since 16Jan2021, he started having symptoms, fever, cough and Diarrhea. On 17Jan2021 the patient was positive to SARS-CoV-2 test. On 19Jan2021 she received monoclonal antibody therapy. The outcome of the event was not recovered.

Could not raise my arm the next morning with out extreme pain from the site to the arm pit to the neck. Then my arm pit was swollen, hot and the swelling went down my arm. I also had diarrhea, Nausea, slight head ache, chills, body ache with a temp of 101.5. Went to the doctor yesterday because of my armpit swelling, hot to touch and it had a red band. She said where they gave it was not in a muscle. It was given sub Q & that it went into my lymph gland and leaked down my arm to swell. Right now I just have on and off nausea , pain in my lymph glands in my arm pit. The swelling and pain has gone down and the other symptoms have faded away.

Evening of vaccine. Slight itching. Day after vaccine - Headache, mild "fever /chills" No Rigor, All over body aches worse than flu, fatigue.

For about 24 hours soreness in left arm near injection site, more swelling and a lump under left arm and burning sensation under left arm and chest area where I typically have swelling and numbness due to lymphedema post mastectomy. Resolved within 24 hours with no treatment.

On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt. Nothing helped taking Acetaminophen; Ibuprofen. She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone. Then you had hives located behind the right ear and down the neck, into the right shoulder. They are also in her scalp. They have now down to the tops of her legs, hips, and back and are spreading. She called her doctor who called her in some prescriptions.

The skin on my arms and legs (mostly noticed arms) looked marbled red immediately after vaccine. It is still there but not as bad as it was initially. I googled skin conditions and it looks like Livedo reticularis. I went to my Cardiologist on 2/5/21 and he took bloodword CBC, Prothrombin Time and bloodwork was normal. Cardiologist told me to go to a dermatologist. My arm was sore also where the injection was and it was hard to lift my arm. That lasted one day. I also had aches and pains and was fatigued on 2/3/21 for 24 hours.

on 2/6/2021 woke up in am with headache, chills, temperature . Symptoms continued with chills, sweating, lethargic with muscle aches and pains along with temp. Temperature returned to normal in pm on 2/7/2021. Muscle aches and pains, itchy at injection site and being tired lasted another couple of days. Feeling back to normal by 2/10/2021

pt reported mild dull headache and warm head.given water and saltines with improvement. BP slightly elevated. Pt admitted to stress. Monitored for additional 30 min. Pt felt ok to go.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched. It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it. I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes. The itching sensation continued off and on the next day but bumps weren't visible any longer. The itchy eyes continued off and on for the next day as well.

Sore arm at injection site. Itchy throat and itchy body. Extreme Fatigue. Heavy and fast heartbeat with severe pressure and chest pain. Ongoing muscle and joint pain that moves from location to location. Redness on chest and facial - cheeks.

Soreness at site of injection; loose bowels; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported for 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247) via unspecified route of administration on 26Jan2021 at 02:30 PM in left arm at single dose for COVID-19 immunization in the workplace clinic. There was no other vaccine administered in four weeks. Medical history included gluten intolerant. No Known allergies. Concomitant medication included calcium, ergocalciferol (VIT D), ibuprofen (ADVIL), multivitamin. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient experienced soreness at site of injection and loose bowels on 27Jan2021 at 07:15 AM. No treatment was received for adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was not recovered. No follow-up attempts possible. No further information expected.

8:30 pm - extreme shivering, teeth chattering, extremities freezing cold, particularly the feet; severe body aches; injection site throbbing; upset stomach and a feeling of nausea. Temperature 100.2 at 8:45. Took temp every hour. By midnight temp reached 102.7. Head ache started. Couldn?t sleep on my left side because of the extreme pain around the injection site and down my left arm. Finally fell asleep around 2:30 and woke at 5:30. Fever was gone. Temp read 98.9. Body aches still present but not as severe. Arm pain had eased but head ache remained most of the day. Felt much better but just very tired.

Patient was premedicated with Zyrtec 10 mg at 2:15 prior coming to her second appointment. She reported similar symptoms from pfizer Vaccine first dose after 25 minutes of observation for the second vaccine. Reported slight itchiness and facial redness. sightly less than previous dose. The allergist on call was notified, ordered Zyrtec 10mg. Zyrtec 10 mg a/o. Initial BP 176/76 HR 64-sat 100% RA. . BP186/80 - HR 54. HR 60 BP 168/78, Observation 1:1 by RN maintained. BP prior dc 152/79 Hr 58.

The day of the vaccine there was no reaction. Day 2 I woke up with red angry lump at the injection site, about the size of a 0.50 cent piece. Later that day I had a fever of 102.5 and chills. Day 3 the redness had spread and still had the lump. Day 4 or 5 the color changed to purple and the lump had decreased. It took about a week for the lump to go away. I still have a discoloration on my arm where the vaccine was given. It looks a bruise but no pain. The whole time the area blanched well. The first dose I had on my left arm and the next day I had a small welt with redness. I am on my second round of steroids to try and get my asthma under control and had to increase my Advair to the highest dose. My doctor put me on a antibiotic as well with the second round of steroids. My asthma is a little better but not at my baseline.

2nd dose pizer 2/11; 2/12 fatigue, body aches, 2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.

This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.

2/9: redness and blue color and pain around the shot site 2/13: fever 101F, body ache, headache, tiredness, - Tylenol every 5 hours 2/14: fever 99 F, body ache, headache, tiredness, hives on chest, stomach, back, arms, - Tylenol every 6 hours 2/15: no fever, hives fading out 2/16: tiredness, hives cleared up

Felt burning towards the ears and cheeks and some numbness, reported not having any difficulty breathing but felt like she had to take off her mask to get "air", slight numbness in the arms and felt flushed.

I had the shingle injection in between the two covid injections. I've had a itchy rash for 6 weeks on my legs and torso. Some raised welts and some regular rash. Nothing over the counter seems to help much.

Other than mild soreness at the injection site she experienced no adverse reactions during the first 24 hours post-vaccine. On the second day after vaccination she developed chills without fever followed by the appearance of rhinorrhea and sinus headache that persisted for about one week. As she has a past history of genital herpes and this resembled her prodrome for recurrence she self-administered valacyclovir for several days. On the eighth day after vaccination she noted mild hand tingling. The following morning she awoke with numbness and hyperesthesia of the left shin that is still present.There was no persistent tingling and no pins and needles sensation

Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her skin about 8 minutes after the vaccine was administered. She does report the reddened area is itchy. She denies SOB, denies airway tightness, denies chest pain. Her vitals at 1356 hours are a HR of 66, BP of 139/74, RR of 18, Sats 100%, RR 16. Pt took a PO benadryl at 1347 hours per her request as she had already declined further EMS care (ALS and ambulance declined). Her Sxs resolved by 1356 hours. She stayed a few more minutes to be sure her symptoms were completely resolved and left POV at 1407 hours. She will follow up with her physician as soon as she leaves. She has been notified that her symptoms could return.

The vaccine was not injected into the muscle as prescribed. The nurse pinched up the fat on my arm with a short needle. My upper arm swelled almost to the size of a baseball and was red and painful for over one week. I think it was administered SQ although intended to be IM. I am a nurse and thought to myself at the time of injection that the proper technique for administering the shot was not followed, but thought perhaps I could be wrong and the extra swelling might be normal with the second injection. My first injection was in left arm and did not swell and was only sore for a few days. If administered SQ, will the vaccine dose be effective?

1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

Itchiness and Rash: Multiple body areas: between and under breasts, lower back area, under arms. It was also on my left arm around the injection site but that has gone away. Date of 1st dose: 1/8/2021 - ELO140 Date of 2nd dose: 1/29/2021 - EJ1686

While in observation area, patient reported to EMT a rash and itchiness in abdominal area. EMT notified lead nurse on site. EMT assessed patient and reported blood pressure 142/90 mmHg, regular pulse 60 bpm, and respirations 16 breaths per minute. Patient denied difficulty breathing, difficulty swallowing, and chest pain. Patient revealed history of allergies to unspecified medications. Patient offered diphendyramine. Patient refused diphenhydramine. Patient advised to wait 15 minutes for further observation. Lead nurse assessed patient. Patient reported decreased itchiness and denied difficulty breathing, difficulty swallowing, and chest pain. Patient advised to seek emergency care if symptoms progress. Patient left observation area with steady gait.

Rash on neck last for one week. After one week, small bumps still remain 10 days later. Bumps are focused vertically from chin

swelling at the site; redness at the site; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EU9899), via an unspecified route of administration in the left arm on 30Dec2020 at 15:00 as a single dose for COVID-19 immunisation. Medical history included anemia, diabetes mellitus, blood cholesterol abnormal, blood pressure abnormal, and low FE. The patient had no additional vaccine/s administered on the same date as BNT162B2, had no prior vaccinations within four weeks, and had no family medical history. Concomitant medications included liraglutide (VICTOZA; taking for 8 years), labetalol (taking for 20 years), diltiazem (CD taking 20 years), valsartan (DIOVAN; taking for 20 years), rosuvastatin (taking for 10 years), metformin (taking for 20 years), aspirin [acetylsalicylic acid] (taking for 10 years), and iron; all are ongoing. On 30Dec2020, the patient experienced swelling at the site and redness at the site. The patient stated that after the first dose, she noticed a little bit of swelling and redness at the site that went away in 48 hours. She had no relevant tests done. The events did not require any visit to a physician or to the ER. Outcome of the events was recovered.

I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,

Vaccine given 2/9/21. On the afternoon of 2/12/21 I began to have joint pains in my right wrist. By 2/10/21 in the morning both elbows, knees and wrists were sore. Elbows and right knee felt warm to the touch. Nodules or red spots developed around the joints. I could barely walk or climb in and out of the car, the bed, and had a very difficult time standing up from the toilet or a low chair or couch. No fever, but did have a few chills with teeth chattering at least twice.

Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and itching that persisted for 3-4 days.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.

Red, itchy, bumpy, swollen rash on right shoulder extending to right breast. Swelling of left hand, stiffness, hard to move fingers, same rash as above between fingers.

Four days after vaccination my trunk was covered with a red rash that was slightly itchy. The next day it spread partly down my arms and legs. On day 6 I had malaise and fatigue and lessening of rash.

Almost immediate discomfort at injection site, followed by sore shoulder (left) and neck pain as well as headache for 24 hours. One week later, severe joint pain for 48 hours.

On the day of the shot, by Noon I could feel the vaccine moving into my throat and my face. My throat and left cheek started to swell and turn slightly red. I took more Benadryl and called my allergist in the afternoon. They told me I needed to get to the hospital for treatment. At the hospital, they gave me steriods, benadryl and Pepcid in an IV. After allowing this to work, they sent me home with a steriod prescription for 60Mg for the next 5 days. They asked me to follow up with my allergist if I had other issues , they also told me that I would not be able to get the 2nd dose of the vaccine. Over the next several days, I continued to have issues with this redness that had grown over my entire face. I looked like I was totally sunburned. I did not feel well, the redness was very hot, and I struggled with some breathing. I made an appointment on Monday morning with my allergist, and they adjusted my allergy medicine and gave me more asteroids for 5 more days. They advised me to use my nebulizer treatments as needed to remove the heaviness in my chest. This redness and swelling has moved around my body, almost as if I can see where the vaccine is at in my body. It went from my head to my chest/back and right arm. Down to my abdomen, and then down below my knees. In the morning, it is usually in my face and then it moves around during the day. I can feel this fluid moving around in my body because the redness brings swelling/fluid. This last saturday 3/6/2021 was horrible, it was in my right ear and right foot. It was very painful and made me very dizzy. I struggled to walk. Then on Sunday morning, I felt fine all day. Today Monday, it feels like it is in my right foot again, but I feel like It is getting better.

left arm became red and tender 2 days after the shot- and has continued for a total of 3 days without change

swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen lips

Injection site pain, muscle pain, could not raise arm up high, chills, whole body ached, joints hurt, weak, mild consistent headache, nausea, skin sensitivity, feeling like a bad case of the flu for 30 hours. Getting better by Sunday evening. Still not 100% as of Tuesday. Slight headache comes and goes like a sinus infection would feel like.

Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9265, via an unspecified route of administration, in the right arm, on01Feb2021 11:30 at SINGLE DOSE for covid-19 immunization. Medical history included diabetes, high cholesterol, high blood pressure and penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. The patient experienced soreness at injection site on 01Feb2021 11:30. The outcome of event was recovered. No follow-up attempts possible. No further information expected.

This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.

FLARE OF A RASH ON MY LOWER LEGS, HIGHLY INFLAMED AND SWOLLEN, DR. PRESCRIBED TRIAMCINOLONE ON 02/12/21. IT IS BETTER BUT NOT GONE AT THIS TIME.

Fever ranging from 100 to 100.9; Chills; Headache; Soreness at site of injection; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 05Feb2021 at 12:30 PM, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231) on 13Jan2021 at 01:45 PM for COVID-19 immunization (in left arm). The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 06Feb2021 at 02:00 AM, the patient experienced fever ranging from 100 to 100.9 accompanied by chills and moderate headache as well. Fever subsided by the morning of 07Feb2021 and headache was mild by then. The patient also experienced soreness at site of injection on 06Feb2021 at 02:00 AM only if she touches it. No treatment was administered for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient was recovering from the events.

On day 2 of the second dose, had soreness, pain and swelling to injection site, also fever of 100.3, chills, body aches and weakness On day 4 after second dose had severe back pain, painful to walk, despite taking Motrin. Went to doctor and had MRI done. Then by early February started having insomnia, hard time falling asleep and staying asleep . I feel the second dose of vaccine might have caused my immune system to become over active. The back is now ok after rest and physical therapy but the insomnia still persist.

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of left forearm (vaccine administered in left deltoid), which then also started in right arm and upper back. Slight redness noted on left forearm where patient had been scratching but no visible hives or rash. Patient denied any difficulty breathing, shortness of breath, throat tightness or itching. Diphenhydramine 25mg PO x1 dose administered. A few minutes after diphenhydramine administration, patient reported that her eyes had become itchy. 20 minutes after diphenhydramine dose, patient denied any worsening of symptoms, reported lessened itching and opted to leave clinic.

burning itchy red bumpy rash started on left elbow, then spread to right elbow. Went to dermatologist on 2/24 for biopsy (gluten rash, psoriasis) and was prescribed Clobetasol 2x day. Rash dried up with skin flaking and peeling in about 5 days. Second vaccine received 3/4, no rash as of 3/10

mild headache, sore arm at injection site, mild nausea, mild weakness. sore arm immediately after injection lasting 2 days. Headache, nausea and weakness day after vaccination lasting 24 hours.

raised, red rash bilateral hands from inside of thumbs to mid-forarm. provided 50mg of diphenhydramine. observed patient for additional 30 minutes. rash decreased in severity and there were no other symptoms (difficulty breathing, increased heart rate, etc)

sever headache itching over entire torso both began about an hour after injection. Lasted through the evening and night Took Tylenol

Itchy rash looks like mosquito bites on legs, stomach and arms; soreness at injection site, tiredness

Nausea, diarrhea, dizziness, disorientation, shakes, headache, injection site pain - all started around 1 pm March 8 and subsided by 8 am March 9

Patient was receiving an IVIG infusion at the time of reaction. Patient has had infusion many times in the past with no reaction, so we are possibly attributing the reaction to her recent COVID vaccine. Severe hives/boils from neck to knees Itching IV methylprednisolone was administered in the home to control reaction. Her MD prescribed famotidine and loratadine to assist with relieving her symptoms.

whole body sever itching. Scratched shin raw, back had hives, abdomen continues to sporadically itch. Never experienced itching of this nature this before. MUCH BETTER, but not fully resolved. (My Mother had same response to her second Moderna COVID19)

2:30 pm pain in left breast and arm pit. Around 3:30 pm slight headache lasting until 6:40 pm. 12:50 am woke to hot sweating and cold lightheaded and dizzy, nauseous and dry heaves. Rash on shot spot and surrounding area. Skin peeling at bandage area. 11:00 am shot area sore. Bandage area still a rash and slight peeling of skin.Dizziness is gone and nausea is gone. No headache

Burning sensation at injection site, felt itching in ears when administered. Felt sore since vaccine was administered. Today, 03/14, woke up feeling very sore and around 11:45am I began to feel chills, body aches, headache and fever.

Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm) continuous as of this report (3/14/21 12:45am)

I have a swollen uvula with blood red spot on the side. It is hard to swallow and it burns. I will call my doctor tomorrow morning.

INJ. PAIN 3/11/2021 TIREDNESS 3/12 &13/2021 HEADACHE 3/11 & 12/ 2021 MUSCLE PAIN 3/11 & 12/2021 CHILLS 3/12 & 13/2021 JOINT PAIN 3/11/12/13/2021 FEVER 3/12/13/2021 102.5 & 100.2 FEELING UNWELL 3/12/13/2021 I JUST KEPT TAKING TYLENOL TILL I FELT BETTER. I AM FINE TODAY. 3/14/2021

red rash around injection site soreness at injection site had bump on injection site body aches headache

Injection site warm, raised, and red; Injection site warm, raised, and red; Left arm felt bruised after she got the injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL9262, first dose) solution for injection intramuscular in the left arm on 08Feb2021 at 12:00 (at the age of 60-years-old) at single dose for COVID-19 vaccination. Medical history included obesity, arrhythmia (that was fairly under control, and was not life threatening) and palpitations (palpitations from time to time, but this medication did not cause that). Concomitant medications included escitalopram oxalate (LEXAPRO) and lisinopril. Historical vaccine included flu vaccine in Oct2020 and experienced bruised after the injection. After the vaccination, the patient experienced injection site warm, raised, and red on 08Feb2021. The patient experienced left arm felt bruised after she got the injection in Feb2021. The patient has had no treatment for her arm yet. The outcome of the events injection site warm, raised, and red and left arm felt bruised after injection was unknown.

Within 30-40 mins, I had a raised red mark starting at the base of my throat running up to my left nostril. There was a lighter red mark on the right side that stopped just above my chin. There was no burning, itching or soreness associated just the raised red marking. It started to dissipate within 2 hours

3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.

About 13 hours after receiving vaccine I awoke close to midnight feeling ill. I spent the next 3 hours having bouts of diarrhea every 5 to 10 minutes along with chills and feeling hot and abdominal pain. This morning on the 16 of March I feel okay with some fatigue and sore right shoulder at injection site.

Allergic reaction to COVID-19 vaccine (rash on stomach - left side) Began 03/08/2021 cleared up and then reoccurred 03/11/2021 still evident 03/16/2021

This patient was vaccinated approximately 1 hour prior to presentation here with her first dose of the Pfizer COVID-19 vaccine. She felt fine right after her vaccination but as she drove to her destination where she was going to take a walk, she started to develop left-sided facial burning and swelling. That prompted her to call her PCP in that office recommended she come back to the vaccination clinic to be evaluated. I evaluated her at approximately 2 PM.. She was feeling well for the most part with the exception of left-sided facial burning and swelling and a little bit of redness over her left cheek. She denied fevers, chills, itching, other areas of rash, difficulty speaking, difficulty swallowing, tongue swelling, lip swelling, wheezing, chest pain, or difficulty breathing. She recalls a penicillin allergy at age 5 or 6 but cannot remember the reaction. She has never reacted to a vaccine before. Initial vital signs included a blood pressure of 134/73, a pulse that was 70 and regular, and an oxygen saturation of 100% on room air. She had normal mental status and her lungs were clear. The left side of her face was slightly swollen over her left cheek as compared to the right with some slight increased flushing on the left side. There was no stridor, she was speaking comfortably, and her lungs were clear with good airflow. Her heart demonstrated S1 and S2 with regular rate and rhythm. I administered 2 doses of Benadryl, 25 mg with each dose about 15 minutes apart with her last dose at approximately 2:25 PM. I rechecked her vital signs at 2:50 PM and her blood pressure was 138/79 with a pulse of 70 and regular and an oxygen saturation of 99% on room air. Her lungs were clear and she was moving good air. I did take a relook at her face which was improved with decreased swelling. At 3 PM, because she was doing much better, I discharged her to home with instructions to use Benadryl 50 mg when she got home and then 25 to 50 mg every 4 hours today. If she develops any respiratory symptoms such as difficulty swallowing, cough, breathing difficulty, swollen tongue or swollen lips, as well as increased facial swelling, she will call 911 to be evaluated. She should not get the second Pfizer COVID-19 vaccine.

40 hours after COVID-19 mRNA vaccination patient awoke in the middle of the night with itch, swelling, rash on left eyebrow. Subsequent 6 days rash developed into typical herpes zoster (shingles) rash localized over left eyebrow.

60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her eyes and nose. Administered 50 mg diphenhydramine PO. In the minutes thereafter, the pruritis spread to the upper lip, then face and scalp, and became more generalized (but mild) on limbs. She also reported a "dry throat" sensation, but denies throat tightness or itching and did not have any respiratory compromise for the hour that she remained under observation. Symptoms subsided and patient left the facility. Followed up with her later by phone to inform her that her immediate allergic reaction was a contraindication to her receiving the second Pfizer COVID-19 vaccine and that she should not return for a second appointment. Advised that she seek allergist consultation given her history of multiple allergies, and to determine whether there was a common substrate for any of them. Said that she could possibly consider the Johnson&Johnson vaccine thereafter, if she did not have any known allergies to components of it.

generalized pruritic rash and redness, patient describes symptoms as "red and blotchy" Patient taking Benadryl to relieve symptoms. Recommended to see primary provider if symptoms worsen.

Could stand, couldn't walk; Swollen lymph nodes in left arm; neck ache; Frontal headache; Heaviness and soreness in arms; Heaviness and soreness in arms; has a sore spot only where the COVID vaccine was; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN9581), via an unspecified route of administration on 04Feb2021 at 10:20 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included ongoing multiple sclerosis. There were no concomitant medications. The patient previously received the first dose bnt162b2 (Lot: EL3249) on 14Jan2021 for COVID-19 immunisation and experienced couldn't re stand. The patient experienced could stand, couldn't walk on 05Feb2021, frontal headache, heaviness and soreness in arms on 04Feb2021, swollen lymph nodes in left arm on 05Feb2021, neck ache on 04Feb2021 at 22:00, had a sore spot only where the covid vaccine was in Feb2021. Event details: The patient had the second COVID vaccine on 04Feb2021. Was fine that day. Had heaviness in her arm and little bit of headache. Was fine the day of the shot. 04Feb2021, felt a little heavy in the arm where she got the COVID shot. Received COVID vaccine in left arm. Drove home and was fine. Sat down and watched TV and had a frontal headache. Took Tylenol. By the time she went to bed, around 10:00 PM, her neck was so sore to turn from side to side. On top of her arms where shoulder pads would be is there the heaviness was. Both arms became sore. It was manageable and she took Tylenol. Eventually it went away. Friday morning 05Feb2021 when she got up, got to the point where she got out of bed and couldn't get up. There was no possible way for her to get up. Her husband had to buy her a 3-in-1 potty chair so she could just stand and pivot, seriousness was provided as disabling, could understand hospitalization, but confirmed she never went to the hospital. Could not rest that day or go back to the bathroom. Didn't walk anywhere. Was in a chair that she could sleep in. Husband bought her a potty chair. Was able to use the lift on the lift chair later that afternoon. Definitely debilitating. Sister who was an orthopedist nurse had to help her and secured she wouldn't fall. The patient had swollen lymph nodes only in the left arm on 05Feb2021. At time of reporting the patient had a sore spot only where the COVID vaccine was. It was not red. Only sure up underneath and when it was touched. The outcome of events could stand, couldn't walk, heaviness and soreness in arms was resolved on 06Feb2021, outcome of other events was unknown.; Sender's Comments: Based on available information, due to close temporal association, a possible contribution roe of bnt162b2 to the onset of "unable to walk" cannot be excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Face begin to itch, then neck. About 20 minutes later started to notice large hives on face and neck. Very red and itchy. Went to pharmacy to get Benedryl and pharmacist suggested to go to ER immediately. Went to ER and was evaluated and kept for observation. No swelling of tongue or difficulty breathing. Stayed for observation and given prednisone (deltasone) . Given an epi pen and instructed to take benedryl. Hives subsided. No reactions since that night. Arm a bit sore but nothing severe. Seeing an allergist next week as followup.

I already alerted you to the rash and itching. I got a headache starting about 30 minutes after the shot. I started having what looked like bruising all along the veins in my arms and hands. Still have that. I went to the doctor and also found that I had high blood pressure and an elevated heart rate. BP 140/90 and Heart rate 85. My normal heart rate is between 55-60 and my usual blood pressure is 108/70. The doctor gave me a steroid shot. This morning, my blood pressure and heart rate were still high and I still had a headache. Then the headache stopped and I took my blood pressure and it was down to around my usual 108/70 and the heart rate was 60. So hopefully I'm starting to recover from this shot.

Patient presented to ER around 5pm on 3/13 complaining of skin itching - this involved the forearms, chest, under her breast, lower back and trunk. She took Claritin and used hydrocortisone cream before coming into the ER. She received diphenhydramine 50mg PO and prednisone 60mg PO in the ER. she was discharged home with prescriptions for Zyrtec 10mg, Diphenhydramine 50mg a Prednisone taper.

Date and time adverse event started: 3/18/21 1520 immediately 1707 Caller states about 2 hours ago called was given Pfizer in the Left deltoid. Felt slight pain then when needle withdrawn started bleeding. Pressure was applied for about 45 minutes dressing changed two times. now has a band aid over the area. Area is starting to bruise and the patient is getting a headache. Patient has a grape sized hard knot at the injections site. Patient using ice indirectly for 10 minutes on 10 minutes off. Caller questions if vaccine went into the blood stream will it be effective, or does the vaccine need to be placed in the muscle to have time to replicate to be effective. . Does caller need another first shot.

Day 1 (3/7): sore arm, mild headache, fatigue, nausea Day 2 (3/8): more sore arm, mild headache, fatigue Day 3: unable to lift left arm, headache Day 4: sore arm, 3" oval shaped red spot next to shot spot: swollen, raised, itch Day 5: arm better, red spot still itch Day 6: able to lift arm, less sore, red spot smaller, still itch, shot spot still itch too Day 7: arm almost back to normal, red spot diasppeared Day 8: all 10 toes red, swollen, extremely itch, unbearable especially at night Day 9 - 10: different toes itch more each night Day 11 (3/17): visited urgent care - diagnosed fungal infection Day 11: visited Primary Care Physician : referral to visit Podiatrist Day 13 (3/19): visited Podiatrist - diagnosis COVID Pfizer Vaccine side effect, prescription: Betamethasone

Had vaccine on Tuesday, 3/9 and on Thrusday night and Friday evening , my right elbow area was very sore. The pain is very localized and responded to a couple of days of ibuprophen. Started again this week and the arm is swollen/inflammed. Uncomfortable for daily activities like typing or eating. Does respond to ibuprophen. Trying to rest it and have it in sling to rest it.

Itching mostly on upper body, chest back, arms &neck w/o rash started on 3/11/2021 & stopped on 3/15/2021

3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

The patient's arm was slightly red in color and swollen. When felt, there seemed to be a lump where the vaccine was given after 5 days.

swelling where shot was given and could not lift my arm for 2 days. Nausea for 2 days and really tired.

8.5 hours after vaccine injection, I suddenly began experiencing fatigue and extreme joint and muscle soreness. Initially I noticed my knees hurting with radiating pain up into my thighs. My head hurt, particularly at the back of my skull, near my neck. My neck muscles were sore, as were BOTH shoulders - my right shoulder (injection site) was only slightly sorer than my left shoulder. I called a 24/7 nurse associated with insurance company to ask if ibuprofen or tylenol were acceptable treatments for my symptoms. She told me I could take either and alternate if I felt I needed to maximize relief. I noticed the joins in my toes and fingers were hurting. It was frightening to experience tightness in my chest and back muscles. I never felt like my lungs were compromised, there was just a heaviness as the muscles seemed constricted. I felt a slight rise in my heart rate and experienced a few palpitations mostly because I kept pondering how much worse my symptoms could get. I was a little cold, so I decided to go to bed after drinking extra water (also a suggestion from the nurse). I slept for a few hours 10:00 PM - 4:00 AM then got up and called an advise nurse to report that my joint and muscle pain were not subsiding. She encouraged water and more painkiller. As the day wore on, I felt less achy and more shaky/jittery. My thinking was somewhat unclear - I felt a little dizzy, out of balance, off-kilter and brain "foggy." As I write this 36 hours after my injection, my symptoms are subsiding. Where I felt a little chilled during our cool and rainy afternoon, I now feel a wave of heat sort of traveling through my body. It isn't a fever - just an odd sensation that something is still going on.

About 45 minutes after the injection two large spots on the face had hives, moderate swelling beneath right side of lip, minor swelling beneath left side of lip. Took Zyrtec and symptoms went away.

Rash and hives, itchy and swollen lymph node on right neck - appeared approximately 24 hours after second dose of vaccine. Received one shot of steroid and prescribed a 6 day dose of oral steroid.

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient stated started next day, reddness, used coritsone and the spot began to grow, now is red and hot to touch, but no longer painful. Thinks it may be celluilitis and is going to check with primary MD as follow up.

Swollen lymph nodes under arms and in groin, headache, pain at injection site, tiredness, fever, chills, felt unwell

At about 3:55PM my left arm, where injectiion was administered began tingling from upper arm to fingers. Pain to the back of my neck, a flush of warmth to my upper body and difficulty breathing. Felt like a truck ran over my chest. I was weak, dizzy and nauseous as well. The tingling sensation also affected both my legs. The RN took to their infirmary area and began taking my vitals. Vitals seems normal, Blood Pressure and Pulse were high. I am asthmatic but did not bring my inhaler with me. Because of my difficulty breathing, they decided to inject me with Benadryl which is all they had. After about twenty minutes, my breathing started to calm down and blood pressure began coming down as well.

Extreme arm pain, swelling at injection site as well as intense itching. Used extra strength Tylenol, store brand antihistamine and extra strength Benadryl cream.

Pfizer-BioNTech COVID-19 Vaccine EUA: nine and thirteen days after vaccination patient evaluated for persistent, raised, pruritic rash on chest. Patient reports reaction is similar to previous allergic reactions to shrimp. Did not take any medications to treat rash prior to first evaluation. Patient denies wheezing, dyspnea, fever, chills, myalgias, arthralgias, bleeding, nausea, mouth sores, and angioedema. Vital signs within normal ranges. Patient advised to use diphenhydramine.

Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days

She started noticing about an hour and a half after she got her vaccination that the injection site started turning red and her arm started swelling from her shoulder down to her hand. She has started taking Advil and icing her arm. It has improved since the evening after she received her vaccination.

Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious. Information on the lot/batch number has been requested.

At approximately 11:05, patient, reported to her vaccinator that she had a reaction of rashes and itchiness after she received the first dose of Pfizer BioNTech Covid-19 Vaccine (LOT# EN6198; exp. 06/30/2021) on 02/27/21 at 10:59 AM. Vaccinator immediately reported to lead nurse at vaccination site. Lead nurse assessed patient history. Patient reported reported itchiness on torso, scalp and left breast approximately 5 minutes after first dose. Patient offered oral diphenhydramine in observation area. Patient declined diphenhydramine. Patient went home and stated she noticed redness and rashes before going to bed. Patient reported redness and rashes extending from deltoid to elbows on both left and right arms. Patient took bendadryl to alleviate symptoms. Symptoms lasted for approximately 3 weeks. Patient also reported no reaction to prior vaccinations. Patient reported talking to her doctor after first dose. Patient advised to apply hydrocortisone cream before 2nd dose of Pfizer and to take benadryl after 2nd dose was given. At approximately 11:11 lead nurse elevated situation. Lead nurse advised to not give patient her 2nd dose of Pfizer, offer Janssen as her 2nd dose, and recommend patient to see an allergist. Patient agreed to take Janssen as her 2nd dose. Lead nurse recommended patient to see an allergist and took patient contact information to set up her appointment for Janssen as her second dose.

Pruritis, shortness of breath Patient to the hospital via EMS. Vitals remained stable and lungs clear. Vitals upon discharge 164/99, HR 86, oxygen saturation 98%. Patient was observed until 12:15pm and was wheeled out to her transportation service.

She has shoulder injury related to vaccine administration with decreased range of motion of shoulder, pain at deltoid and pain with overhead activities that persists, albeit some improved, for 2.5 months post vaccination

Symptoms were minor--soreness at injection site for 2 days, loose stool the day after injection, and minor headache and fatigue on the day after injection through the following day (2 days after injection).

After coming into the observation post vaccination, the patient told the nurse that she was itchy. The nurse assessed her and did not note any hives but did see scratch marks. Soon after, the patient stated she felt hot and had a headache. She quickly noted that her throat had begun to also hurt at that time. EMT's came over to assess her, per the nurses request the EMT's at that time suggested to the patient that she be further evaluated at the hospital. She accepted the transport to the ER.

Body aches and chills at first. On Sunday 3/21, my fever spiked to 103.7. called doctors office. Was told to take Tylenol for fever and if it didn't drop to the walk in or ER. It finally dropped later that evening. Then the next day 3/22 i have a rash on my arm i received the vaccine in. On 3/24 it was worst. put a call back into the doctors. Said if it continues to get worst to go to the ER. I put ice and cortisone cream on it which helped take the itching away.

this was my 2nd dose. late afternoon & was feeling unenergetic. late that eve I felt achy, took 400mg ibuprofen before going to bed around 11pm. by 1 am on 3/24 I was running a fever, shivering & my inj arm was very sore/felt heavy. Took 400 more ibuprofen, fever reduced before too long. Also felt slightly nauseous during the night & into the day of 3/24. around 2 pm got a bad headache. more ibuprofen, still felt a little nauceous, tho that subsided in early a.m. 3/25. Also was coughing quite q bit most of 3/24, but that may have been due to allergy stuff. experienced some mild diarrhea on 2 occassions 3/24. Symptoms are fairly well abated by 10a.m. 3/25.

Itching from my head that progressed to my knees by early afternoon. No hives or anything else. Resolved after two doses of benadryl about 4 hours apart. Woke up next morning feeling fine.

1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.

2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breathing and lip swelling at 7pm. Brought to ED, given epipen and methylprednisolone. Monitored closely overnight, symptoms resolved by AM.

Pain in left arm for about 30 min. followed by numbness in hand, then ring finger fingertip completely white that lasted about 10 min. Once color returned I soon became dizzy and weak feeling in my legs followed with vomiting. I then felt a little better with mild light headedness.

Within four hours of shot, low grade fever, 101.4, chills, nausea, exhaustion. Asleep by 9:00p.m., slept 13 hours, On March 17, woke at 10 am. Nausea, fever, chills gone, but totally exhausted with burning sensation at shot site and soreness in upper right arm. Remained in bed all day, asleep by 6 pm. Remained exhausted through March 23. Any physical activity caused shortness of breath and further tiredness. Exhaustion dissipated by March 24, 2021

1. Some Swelling and redness at injection site 2. Some lymph node swelling and discomfort under right arm Outcome not known yet, swelling and redness seem to be lessoning.

Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.

Site: Pain at Injection Site-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: vomiting-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

Shortness of Breath; Urticaria; Bronchospasms; Flushing; redness; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot EN5318) via an unspecified route of administration in left arm on 09Mar2021 at 10:00 AM (at the age of 60-years-old) at single dose for COVID -19 immunisation. Medical history included systemic lupus, asthma, rheumatoid arthritis, thyroid cancer. She had allergies for antibiotics, pneumovax and morphine. She had taken other medications in two weeks. No other vaccine in four weeks was received. She experienced urticaria, bronchospasms, itchiness, shortness of breath, flushing/redness on 09Mar2021 at 10:15 AM. The adverse event was resulted in emergency room/department or urgent care. She was treated with IV fluids, benadryl, decadron and solumedrol. She did not have COVID prior vaccination and COVID tested post vaccination. Outcome of events was ecovering. No follow-up attempts are possible. No further information was expected.

rash; itchiness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration, in the right arm on 26Feb2021 at 15:45 (at the age of 60-years-old) as single dose for COVID-19 immunisation. Medical history included cardiac murmur, allergy to walnuts, and shellfish, allergy to penicillin, bilateral stenosis of ureters, and obesity; all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received unspecified concomitant drugs within 2 weeks of the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took morphine and experienced drug hypersensitivity. On 26Feb2021 at 17:00, the patient experienced rash and itchiness. The patient was given diphenhydramine (BENADRYL) as treatment for the events, rash and itchiness. The patient recovered from the events, rash and itchiness on an unknown date.

Sore left arm at injection site; Tingling feeling on forehead; Slight headache; neck pain; This is a spontaneous report from a contactable Pharmacist. A 60-years-old female patient received BNT162B2 ( BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL3247) first dose via an unspecified route of administration, administered in left arm on 18Feb2021 9:15 as single dose for COVID-19 immunization. Vaccination administered facility Workplace clinic. The patient medical history included Osteoporosis; irritable bowl syndrome. The patient concomitant medications included : Citracal; Centrum; Vit D (ergocalciferol); Colace; Evening Primrose (oenothera biennis), ascorbic acid, biotin, calcium carbonate, calcium pantothenate, calcium phosphate dibasic, chromium picolinate, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, magnesium borate, magnesium oxide, manganese sulfate, nickel sulfate, nicotinamide, panax ginseng root, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium metavanadate, sodium molybdate, sodium selenate, stannous chloride, thiamine mononitrate, tocopheryl acetate, zinc oxide (CENTRUM ENERGY). On 18Feb2021 10:00 patient experienced with sore left arm at injection site (vaccination site pain), tingling feeling on forehead, slight headache, and sore neck on left side. The outcome of the event was recovering. Follow-up information was received on (25-MAR-2021): No new medically significant information was received on this case.

Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.

Hives including 1 that was blister like; Redness on arm; itching; arm soreness; This is a spontaneous report received from a contactable consumer. A 60-year-old (age at vaccination) female consumer reporter for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; ER8727) via an unspecified route of administration on 23Mar2021 at 11:45 am at single dose on left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Vaccine was administered at hospital facility. Patient's medical history included COPD mild (Chronic obstructive pulmonary disease) and allergies to medications, food, or other products (unspecified). Concomitant medications included (received within two weeks of vaccination) inhaler and vitamins (drug name unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Hives including 1 that was blister like, redness or arm, itching and arm soreness on 23Mar2021 at 01: 15 pm. Self- warm compression initially then iced was the treatment given. It was unknown if the patient was diagnosed with covid-19 prior to vaccination. Patient was not tested for covid-19 since the vaccination. The outcome of events was unknown. information on lot expiry has been requested.

Lower right leg vein popped out about 1/2-3/4" - didn't feel anything; Lots of petechiae from back to feet; Blood blisters; Turned into bruise; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Mar2021 21:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included allergies: anesthesia and thrombocytopenia that developed during childbirth (went away after a few weeks). The doctors said that it may have been a drug reaction. Concomitant medication included omeprazole (PRILOSEC). The patient previously took codeine and experienced allergies -severe nausea. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 08Mar2021 18:00, patient's lower right leg vein popped out about 1/2-3/4" but did not feel anything. It later turned into a bruise. Lots of petechiae from back to feet and blood blisters noticed; large on torso. AE resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No treatment received for AE. It was also reported that the events caused hospitalization. Platelets were tested last week (unspecified date in 2021) and are on low end of normal range. Outcome of the events was unknown. Information on the lot/batch number has been requested.

On 3/31/21 woke with severe skin pain on entire left thigh. On 4/4/21 the pain continued and then there was a rash all around my thigh. The pain is still present and the rash has gotten worse. I went to my doctor on 4/6/21 and he says the event is caused by the vaccine. He said the symptoms resemble shingles but also varies from shingles.

Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.

Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.

1) Extensive spots, reticular discoloration of the legs, some spots redder than others. In calves of both legs. 2) Sharp breast pain, on the left breast,

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported significant swelling and a 4 inch raised hive at injection site. Patient took Benadryl and it went down and resolved after a few days. Reaction started on day 8 after injection.

I had all this pain at the injection side; tired; headache; chill; throat pain; fever; nausea; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at age of 60 years) at single dose for COVID-19 immunization. Patient relevant medical history included chronic obstructive pulmonary disease (COPD). Patient concomitant medications were not reported. After receiving covid-19 vaccine patient started running really high temperature and pain at the vaccination side, really tired, headache, chill, throat pain, fever, nausea, Patient said swollen lymph nodes, throat has been sore on unspecified date. Patient stated that run temperature but took Tylenol and it took it down it was high, but I still have the soreness. Patient also mentioned having COVID 19 infection months ago. Treatment received for events was unknown. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Patient had flushing/sweating, rash. Given Benadryl 25 mg PO. Patient stable, released from vaccination site.

Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck. Went to dr rash not there. Treated for shingles. Rash reappeared later that evening. Husband received vaccine same date/time. Being Treated for shingles. He reported his event

Back disorder; lower back issues; Feeling abnormal; felt fuzzy; Vaccination site pain; sore arm; Dizzy; Fatigue; Energy decreased; not feeling as much energy as before; Pain upon movement; walk about a block but then starts to hurt; This is a solicited report from a contactable consumer (patient) via a non-Pfizer sponsored program, based on the information received by Pfizer (Manufacturer Control No: 21K-163-3774842-00). Solicited report from a consumer of a 60 year old female with events of heart/atrial flutter, atrial fibrillation, eye surgery and arm surgery and non-serious weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt with humira 40mg/0.4ml (adalimumab). The patient had a relevant medical history of tobacco use/four cigarette sticks per day, seropositive high titer rheumatoid arthritis, fingers swelling, joint pain, joint swelling and lost of blood flow in hands and legs. On unknown dates, the patient experienced eye surgery, arm surgery, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery, still not feeling as much energy as before and walk about a block but then starts to hurt. In 2020, the patient experienced heart/atrial flutter and atrial fibrillation. In Sep2020, the patient experienced weight gain due to attempting to stop smoking. On 24Feb2021, the heart/atrial flutter and atrial fibrillation resolved. Covid-19 vaccine was also considered suspect. The patient had eye and arm surgery in the past. On 24Feb2021, she underwent pulmonary vein cryoballoon ablation surgery for the atrial fibrillation and atrial flutter. She had a procedure done and went into her heart and froze the nerve endings that were causing the atrial fibrillation, and also fixed the flutter in her heart. The causality as per reporter for this procedure was reported as no reasonable possibility. She still recovering. She discontinued the Humira two weeks before the surgery and took her last injection on 10Feb2021 and was paused it for four weeks, but she started back it on 10Mar2021. She follows up with her surgeon at the end of the month and she hopes this helps got her off of the blood thinners and other medicines, she been on for this. She stated that this was not related Humira. She was advised by her physician to increase the exercise to lose some weight. With her lower back issues, she was hoping that when she got off of the blood thinners, she could do pain shots again and start exercise. She could walk about a block but then she started to hurt. She had been careful with her diet also, cut out the salt also. This had nothing to do with Humira and she did not want to be contacted about this again for this also. She felt fuzzy, it took her most of the morning to get woken up. Her Doctor thinks once she would off of the blood thinners she would be back to normal. Other than that she feels fine. She does not wanted to be contacted about this. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received first dose COVID-19 Vaccine manufactured by Pfizer, lot number unknown. She agreed to have physician contacted. Blood thinner was also considered as co-suspect. Other medical history included abstains from alcohol, contrast dyes allergy manifested by scratch throat, allergy manifested by bowel movements (oral medications for rheumatoid arthritis; up to eight times a day and slept 15 hours per), prevent esophagus damage, heart, low thyroid, and attention-deficit/hyperactivity disorder. The patient's concomitant medications included pantoprazole to prevent esophagus damage, metoprolol for heart, levothyroxine for low thyroid, vortioxetine hydrobromide (TRINTELLIX) for depression, and dexamfetamine sulfate (DEXTROAMPHETAMINE) for attention-deficit/hyperactivity disorder. The patient underwent laboratory tests and procedures which included blood work: everything was fine in Jan2021; chemical stress test and treadmill stress test: confirmed atrial fibrillation and atrial flutter in Sep2020; body weight: gain in Sep2020; and X-ray: confirmed atrial fibrillation in Sep2020. The action taken in response to the events for adalimumab and apixaban was unknown. The patient recovered from atrial flutter and atrial fibrillation on 24Feb2021. Outcome of Feeling abnormal and Pain upon movement was unknown. The patient had not recovered from the remaining events. Change History: On 05Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, past drug information, laboratory/diagnostic procedures and narrative description. The events of "atrial flutter", "atrial fibrillation" and "weight gain due to attempting to stop smoking" were added. On 11Mar2021, received updates to patient demographics, medical history, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "LOWER BACK ISSUES" and "WALK ABOUT A BLOCK BUT THEN STARTS TO HURT" were added. the event of "atrial flutter" was amended to "heart/atrial flutter". On 08Apr2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "felt fuzzy", "got first dosage of covid-19 vaccine and experienced sore arm", "fatigue and dizzy from the blood thinners after surgery" and "still not feeling as much energy as before" were added. Causality for humira 40mg/0.4ml(adalimumab): The reporter's causality for the event(s) of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood THINNERS after surgery unknown onset and fatigue and dizzy from the blood thinners after surgery unknown onset with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of felt fuzzy, still not feeling as much energy as before and walk about a block but then starts to hurt was not provided. Manufacturer opinion is that there is no reasonable possibility that the events of heart/atrial flutter, atrial fibrillation, eye surgery, arm surgery, weight gain due to attempting to stop smoking, lower back issues, felt fuzzy, got first dosage of covid-19 vaccine and experienced sore arm, fatigue and dizzy from the blood thinners after surgery unknown onset, fatigue and dizzy from the blood thinners after surgery unknown onset, still not feeling as much energy as before and walk about a block but then starts to hurt are related to humira 40mg/0.4ml(adalimumab). The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information , the events of sore arm, fatigue and dizzy could be related to the suspected drug of BNT162B2. The other events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

started scratching and now the holes are open on areas to her chest; stated that the left side of her face is hard as a rock; Has rash on left side of face down to chest with blistery spots; could not breathe/cannot catch her breath every now and then; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 60-year-old, dose 1 via an unspecified route of administration, administered in right arm on 17Apr2021 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included high blood pressure; and bad feet since 2004. The patient's concomitant medications were not reported. The patient had first vaccine on 17Apr2021. On 18Apr2021, she had a reaction, could not breathe. She cannot catch her breath every now and then and had to use the Epipen. Has been using nebulizer. Has more Epipens in case something else happened. Stated that she has a rash on the left side of her face down to her chest with blistery spots and that the left side of face was hard as a rock on 19Apr2021. Stated that the rash was worst on her chest. Has put some cream on the rash but it burns. Had a pain cream called Volten that she put on it because the rash was painful but that made it worst. Stated that she started scratching and now the holes are open on areas to her chest on 21Apr2021. Stated that she had to wear low shirts because her shirts were rubbing her chest. Stated that she was told by her doctor not to take the second shot that was scheduled for 17May2021. Stated that she has scheduled doctor's appointments that were fine. The patient wanted to know if she could get something in writing to submit with her passport stating the she could not have the second shot. The outcome of the event could not breathe/cannot catch her breath every now and then was recovered with sequel, and for the rest of the events was not recovered.

April 1, dark urine April 2, Fatigue, injection site pain dark urine April 3, Extreme fatigue, dark urine Jaundice went to urgent care, they advised i go to ER as they felt i needed an abdominal scan to see why i had so much bilirubin in my urine. Went to Hospital. CBC showed my hemoglobin was 5.9. Went down to 4.9 before first transfusionhad CT SCan and sonogram.. Was admitted and disagnosed with hemolytic Anemia brought on by Covid Vaccine. had 5 blood transfusions over the course of my 8 day hospital stay. As of 5/06/21 My hemogloblin is 10.3 and has been at this level for past three weeks, I am currently under the care of a hemotologist

12/28 developed shingles for the first time. Started antivirals 12/31when vesicles appeared and I realized it was shingles.

Reports the following symptoms: Left shoulder pain, diarrhea, nasal congestion, sore throat, cough, Itching all over body, scalp pain and tenderness. 12/28 Began feeling better, mild cough persists. 1/4: Feels as though she has "bad flu" fever of 101 F.

Developed itching on right side of face between temple and earlobe while driving home. Once home was noted to have 3 dime sized hives in that area which lasted approximately 2 hours and then resolved without intervention or further adverse event.

Patient describes feeling feverish, joint aches in elbows and knees, body aches, red rash at knees and elbows and arm pain at injection sites. This is the 2nd dose, patient reports no adverse reactions on the first dose.

VACCINE SAT AT 1:30 PM, SUNDAY 9:00 AM FEELING TIRED NAUSEATED, TEMP UP TO101 THROUGH THE DAY, HEADACHE,PAIN IN LEFT ARM AT INJECTION SITE. TEMP SEEMED TO BREAK THAT EVENING 98.0 . MONDAY INJECTION SITE VERY RED AND RAISED, ITCHY, ABOUT 1 TO 1 1/2 INCHES IN SIZE. TODAY TUESDAY SAME SIZE ITCHY NOT RAISED .

development of rash on arms, itchy feeling on arms and torso; feeling of increased warmth all over body--temp 96.8 temporal but felt very, very warm took Benadryl rash faded, decreased itchiness

rash/legs are all rash/checked her back and told her there was a rash; itchy in back; This is a spontaneous report from a contactable healthcare professional. A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 22Dec2020 at left arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetes from about 3-4 years before, and an allergic reaction to the dye when testing heart - couldn't remember the dye put in. She was allergic to that and sent to the ER because her throat was starting to close up about 3 years before. Concomitant medications were none. Patient received the Covid vaccine and developed rash on 24Dec2020 that was worsening and she asked if there was any recommendation on whether this was it going to get worse. Patient received the vaccine and was very worried because she was really itchy in back and her legs were all rash and in her back. She was starting to itch really bad. This was after 2 days of the vaccine (on 24Dec2020). She didn't take note until it came to her back and her friend checked her back and told her there was a rash. She asked if this could be related to the vaccine. She asked was this a severe reaction and should she receive the next dose. Her second dose was scheduled for 08Jan2021. She did not know at this time if she would get the second dose as scheduled or not. Onset of rashes started on her legs; she thought it would go away; but the rashes had worsened; they were now on her back and were getting really itchy; she had a friend look at it who told her she had patches of rashes on her back. She reported that she was going to contact her doctor about this information because she was scared about the rashes. Outcome of the events was not resolved. Lot/Batch and Expiration date has been requested.

Ee stated upon observation entrance, that she would be observed until 10:15am r/t "anaphylaxis" to Morphine. Informed us that she became "itchy" for "3" days prior to the 1st dose on 12-16-20. Ee c/o "itching" to this nurse @ 1005. Benadryl 25mg given @ 1005. Remains to c/o "itching" @ 1015. Ice pack applied to chest to relive itching @ 1015. Around 1025 Ee stated she felt "relief of itching". This nurse also gave Ee (1) Benadryl 25mg to take w. Her. Ee stated she was feeling better @ 1034. Left observation @ 1035.

Pfizer-BioNTech COVID-19 Vaccine EUA Beginning one week after receiving the injection, the site has a red spot about the size of a quarter and feels slightly irritated. It has been this way for approximately 24 hours.

Shingles; This is a spontaneous report from a contactable nurse reporting for herself. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number PAA156571) via an unspecified route of administration, on 20Dec2020, single dose for COVID-19 immunization. Relevant medical history included hypercholesterolemia. Concomitant medications were not reported. The patient took unspecified medication for hypercholesterolemia however the patient stopped taking it for a month or two already. The patient got the first Pfizer vaccine shot on work (clinic) on 20Dec2020. On 28Dec2020, the patient developed shingles which is now being treated. The patient does not know if this is because of that or a part of it. The patient never had Shingles before. Outcome of the event was unknown.

couldn't lift my head off my pillow; severe pain in neck; squeezing on a nerve; had soreness in my arm; This is a spontaneous report from a contactable nurse, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 18Dec2020 (at the age of 61 years old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 18Dec2020, the patient experienced soreness in her arm that was gone by the next day. On 23Dec2020, while driving home, she felt severe pain in neck. She almost felt like something went up in her neck and started squeezing on a nerve. It proceeded to get bad so she took muscle relaxants. Christmas day was horrible, she couldn't lift her head off her pillow. The pain came from up head, under her clavicle and down her back. Her pain started getting better, but then next morning it up started again. The only way she's able to get some sleep is to take Flexeril, 800mg of Motrin and applying moist heat. The clinical outcome of severe pain in neck, squeezing on a nerve, couldn't lift her head off her pillow was unknown, and for event had soreness in her arm was recovered on 19Dec2020. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

pain in arm at injection site; This is a spontaneous report from a contactable other healthcare professional (hcp). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1284, expiry date not given), intramuscular on 29Dec2020 18:00 at a single dose in the left arm as Covid Vaccine. Medical history included hypothyroid, low adrenal cortex and allergies to sulfa. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medication included fluoxetine. The patient had no vaccine in four weeks. The patient previously took amoxycillin and experienced allergies. On 29Dec2020 (reported as at 5:30 AM and 5:00 AM; pending clarification), the patient experienced pain in arm at injection site. Since the vaccination, the patient has not been tested for COVID-19. The event reported was not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect. The outcome of the event pain in arm at injection site was recovering.

2 days after receiving 1st vaccine, began with hives and itching to arms face and torso. Also after 24 of receiving 2nd dose began with hives and itching to face hands and arms.

Headache, Myalgia, Arthralgia, Chills, Fatigue, Injection Site Pain Narrative: Adverse reaction lasted 3 days, employee did not report to work on day 3 after vaccine.

Mild- moderate tenderness in left deltoid; This is a spontaneous report from a contactable physician. A 61-years-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number=EK 9231, via an unspecified route of administration, in left arm, on 30Dec2020 at 13:45 (at the age of 61 years-old for COVID-19 immunization. The vaccine was administered at a hospital. Medical history included allergic rhinitis, a distant history of thyroid cancer and an allergy to iodine. Concomitant medication included biotin (BIOTIN), cetirizine (CETIRIZINE), fish oil (FISH OIL), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), levothyroxine sodium (SYNTHROID). . The patient has not had any vaccinations in 4 weeks. The patient has taken other medications (concomitant medications) within 2 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 31Dec2020 at 0700 the patient experienced mild- moderate tenderness in left deltoid. The patient was not hospitalized for the event nor received any treatment. The clinical outcome of the mild- moderate tenderness in left deltoid was recovering. Since the vaccination, the patient had not been tested for COVID-19.

Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.

1st day of inj the expected side effect of inj site very sore and fatigue for 25 hours. Day 8 after receiving the vaccine, at 2 PM started with itching of scalp, arms, legs, rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck. Took 50 mg Benadryl w/ some relief. 630 PM symptoms reoccur, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER at 830 PM

Chills; dry cough; no appetite; fatigue; pain at injection site; general malaise; general aches; temperature 102; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer-BioNTech ;lot number: EK9231) intramuscularly at right arm on 02Jan2021 at 07:45 A.M. at a single dose (dose number: 1) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 on 07Dec2020. No known allergies (no allergies to medications, food, or other products) and no other medical history. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination were none. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse events included chills, temperature 102, general aches, fatigue, pain at injection site, dry cough, general malaise, no appetite. Temperature elevated till 03Jan2021, 6pm. Symptoms similar to what she experienced when diagnosed with covid-19 on 07Dec2020. All events with start date on 02Jan2021 at 06:00 P.M. The events were reported as non-serious. No treatment received for events. The outcome of events was resolving. Since the vaccination, the patient had not been tested for COVID-19.

Headache Malaise and frequent stools but not considered diarrhea Narrative: She states that she had immediate pain at the injection site. On Saturday at 7AM, she developed malaise and frequent stools but would not classify them as diarrhea as well as a headache. She has never had a fever. Today, she continues to feel weak but reports that she is improving.

Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.

About 5 minutes after receiving vaccine: suddenly- Felt hot all over; feeling of anxiety; and left deltoid muscle felt completely numb; palms slightly flushed, felt as if heart rate slightly elevated, but not tachycardia. No rash, no hives, no difficulty breathing. Acute episode lasted about 20-30 minutes, then just felt a little off for 1.5 hours more, then back to normal. For next 34-48 hours-mild fatigue.

Extreme skin sensitivity to torso (chest & back) on left side parallel to the injection site, shingles type sensitivity without a rash or redness

muscle pain in left shoulder blade and under left breast; rash which resembles shingles without blistering; redness on left should blade and over left breast

24 hrs- chills, Headache,LA sore, wheezing, fatigue Took Tylenol 3 times, using Proair inhaler 48 hours- more chills, more wheezing, LA still sore Took Tylenol twice, using inhaler 72 hours- LA still sore, skin red over deltoid and biceps with tenderness, still wheezing, using inhaler throughout day Symptoms somewhat controlled with repeated doses of Tylenol and Proair

Raised red itchy rash on left palm of hand, evaluated by pharmacy, diagnosed as Shingles onset same day as Covid-19 vaccine obtained.

Received her 2nd dose of the covid vaccine on 1/8/2021. No side effects all weekend. Woke up on 1/11/2021with systemic hives, rashes that itch. Denies prior reaction to previous variance dose #1 on 12/18/2020. Denied any difficulty breathing or SOB. Took 25 mg of Benadryl this am and then called PCP who is a OB who said to take 50 mg of Bendery and if symptoms do not improve go to Urgent Care. Follow-up call made by provider 1816: Employee reported going to Urgent Care where she recieved Soulmedrol IM and an AB test. Hives covering entire body and scalp.

Slight headache the night I received the dose, shot site redness and muscle pain for 2 days after receiving dose

injection site soreness and swelling, sore are with in 1 hour, lasted 48 hours, diarrhea started 13 hours after injection lasted 72 hours. headache started 12 hours after injection lasted 60 hours tiredness started 4 hours after injection lasted 48 hours I only took tylenol

Patient reported rash on left wrist approximately 10 minutes after receiving vaccine. Also reported pruritus at site of redness. Patient was monitored by provider and throughout duration of monitoring developed rash on wrist, neck, and left forearm with pruritus at all sites. Patient given 50mg of Benadryl PO approximately 25 mins after reaction. Within 30 mins of administering medication redness and pruritus had resolved and patient left clinic in stable condition.

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

Soreness and swelling at injection site; Soreness and swelling at injection site; Malaise; feels tired; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP (Patient) reported for a 61-year-old female patient received the first dose of BNT162b2 (lot: EK92331), intramuscular at left arm on 04Jan2021 (approximately between 18:15-18:30) at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications included supplements. The patient experienced soreness and swelling at injection site, malaise and feels tired on 05Jan2021 08:00. She was scheduled for second dose a day later for COVID vaccine so after the 21 days to get her second dose. Patient is a Dental Hygienist. She received the first dose on 04Jan2021 and is scheduled to receive second dose on 26Jan2021. She should have it scheduled for 25Jan2021. There is no prescriber. She received it at a local hospital through her employer. They did not offer her the 25Jan2020, and said next day is 26 days. They told her there would not be any problem being a day late. She called back with a concern and had evening appointment with the intention of being 3 weeks later. She did it while she had 2 days off work in case she had a reaction. She was told it was not a big deal to get it 1 days later. She asked if she could go to a different location and they told her no, it had to come from the same batch and lot to receive second dose. She is just concerned about doing it a day before she has to go back to work because there are worse side effects with second dose. There is a 4 day grace period from what she read of of 17-21 days and not over 21 days. She is not sure if that is true though. The outcome of the events was not recovered.

fever; nausea; general feeling of unwell; soreness at site; redness; whole upper arm was swollen after the injection; This is a spontaneous report from a contactable other HCP (patient, Respiratory Therapist) reported that a 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE , Batch/lot number: EJ1685) via an unspecified route of administration on 21Dec2020 around 6:00 PM in left upper arm at 0.3mL single dose for COVID Prevention. The patient's medical history was covid at the end of Apr/May2020 with shortness of breath, seasonal allergies and allergies to "some anitbiotics." The concomitant medications was reported as none, received no other vaccines on the same day as the COVID vaccine. The patient experienced soreness at site, redness and swelling, fever, nausea, general feeling of unwell 3 days. Patient stated, "I had covid at the end of April/May with shortness of breath. I thought I would have less reaction from the vaccine. I know someone who was out of work for a while week after the vaccine." States that she read that the 2nd dose is supposed to have worse side effects than the first. If she had bad side effects from the 1st dose, will the 2nd be worse? Also asking if the side effects are the immune system reacting or just an allergic reaction. Patient was anxious about getting her second COVID shot on 11Jan2021. Patient stated that she had all the side effects listed, for three days. Patient stated that she didn't mind the side effects at the time, she had fever, soreness at the injection site, nausea, and a general feeling of unwell, but Patient stated that she could not work like that. Patient stated that her question was, statistically she has read that the side effects from the second shot are supposed to be worse than the first shot, but she was wondering, if she had bad side effects from the first shot, will her side effects be worse after the second, or will they maybe be lessened because she already had bad side effects. Patient reported that she did fill out the VSafe significant because she had to work on the third day after her shot, which was Christmas Eve, and work, was so busy and she did not feel well. Patient stated that she does have two days scheduled off work after her next injection, but it is the third day that she was worried about because she does not want to work feeling like that. Patient stated that the arm soreness started that same day (21Dec2020). At first, Patient reported that the arm soreness resolved, but then she states that it is still a little sore to the touch. So Patient confirmed that it is ongoing but improved. Patient reportsed that the fever started the day after the injection, 22Dec2020 and it has resolved. Patient reported that the last day she recorded a fever was on 24Dec2020. Patient stated that she woke up on 24Dec2020 and her temperature was normal, so she went to work and she did not feel so well at work, but they were so busy that she barely noticed, and then when the Patient went home that night, she took her temperature and it was 100 degrees Fahrenheit. Patient reported that the nausea started on 22Dec2020, which was mild at times, but then she got to where she did not want to eat. Patient reported that the nausea has resolved but she was not entirely sure when it resolved because she had been so busy at work on 24Dec2020, and it was hard to tell what she was feeling because she was non-stop busy that day. Patient stated that she was nauseous for a full three days, and she remembered that she did not eat much on the 24th either. So Patient stated that her nausea may have resolved on the third day after her injection, but it is unknown to her what day exactly that it resolved. Patient was also experiencing the general feeling of unwell from 22Dec2020 for a few days, but stated that by 25Dec2020 she felt okay. Patient also included that her left arm was also swollen, like her whole upper arm was swollen after the injection in Dec2020. Patient stated that she also experienced redness, there was a like a red mark that was further down her arm than the injection site in Dec2020. The outcome of soreness at site was recovering. Patient confirmed that both the swelling and redness had resolved in Dec2020.The outcome of fever was recovered on 24Dec2020. The outcome of general feeling of unwell and nausea was recovered on 25Dec2020.

notice a rash on her left hand; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via unspecified route of administration on left arm on 05Jan2021 at single dose for Covid. The relevant medical history and concomitant medications were reported as none. The patient stated that she just got the first shot of COVID vaccine and noticed a rash on her left hand. She stated that it was the same arm that she got the shot. She wanted to know if there was anything that she needed to do. She stated that she got it through the state as a healthcare worker. She stated that she noticed the rash 20 minutes prior to the report. The patient had no treatment for the event. The patient was tested for COVID the week prior the report in Dec2020 and it was negative. She was going in at the time of the report to get another COVID test. The outcome of the event was not recovered.

rash started 15 mins post administration on left arm, and spread to chest, and other arm treated with Benadryl

Itching at site. Removed bandaid. Reddened area in triangular pattern along bandaid and below bandaid approx 3 inches. Site not hot, site firm. By 10:00 pm itching and redness resolved. Site remains slightly firm.

Headache for3 days Nausea for 3 days Muscle weakness for 3 days. Joint pain for 3 days. Red rash at injection site. Swelling at injection site. Diarrhea for 2 Days

chills; body aches; cold; fever; pain at injection site; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable consumer (patient herself) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL0140), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunization. Patient had a history of COVID in Nov2020. Concomitant medication included levothyroxine sodium (SYNTHROID) (for twenty some years), bupropion hydrochloride (WELLBUTRIN) (for about a year), naltrexone (for about a year), all from an unspecified date and ongoing. The patient got the vaccine yesterday (06Jan2021). Patient experienced chills, body aches, cold, fever, and pain at the injection site started at 10 am on 07Jan2021. The fever has went up a little since this morning, but everything else has stayed the same. Her fever was 100.6 degrees Fahrenheit now. Earlier this morning it was 99.3 degrees Fahrenheit. Outcome of events were not recovered.

As stated I fainted about 3 hours after injection. I thought it was because I had worked all night. I fell forward and sustained bruising to my right cheek and temple. I will be reporting another report regarding the second dose with adverse reaction that is the same but required EMS and Emergency Room visit. Approximately 3 hours after injection I was getting ready for bed (as I work nights). I was talking with my daughter and I stood up and remember waking up on the floor. Bruising to the right cheek and temple. I did not seek medical attention and went to bed. I had no further episode but remained dizzy for several days.

Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the events were not recovered.

trouble lifting things like my tea kettle; lot of pain in right elbow; bad neck and shoulder pain; bad neck and shoulder pain; sore right arm similar to after a tetanus shot; This is a spontaneous report from a non-contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number: EL1284, intramuscular on right arm from 05Jan2021 09:45 to 05Jan2021 09:45 as single dose (first dose) for COVID-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. On 05Jan2021 at 03:00pm, the patient experienced sore right arm similar to after a tetanus shot. On 06Jan2021, the pain in upper arm gone but by afternoon but the patient got bad neck and shoulder pain on right side that she treated with heat and Advil. On 07Jan201, neck pain still present and by late afternoon, the patient got a lot of pain in right elbow. On 08Jan2021, the patient still have the neck to shoulder pain in addition to the right elbow pain. It feels like she sprained her elbow and was having trouble lifting things like my tea kettle. The outcome of the event sore right arm/pain in upper arm was recovered on 06Jan2021; having trouble lifting things like my tea kettle was unknown; while the other events were not recovered. Treatment has been given for the event bad neck and shoulder pain. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.

Total body rash with severe ankle and feet swelling and peeling that continues even after getting vaccine more than 3 weeks ago

minor itchy spots torso and neck. started 24 hours after shot. first 7 days just 2 to 3 spots daily. days 9 thru 11 spots increased to about 8 to 10 daily. These spots only lasted about a day. They did not break open, merely disappeared with no lasting marks. There has been no new spots after day 14. No medications was take, it was mild and I wanted to watch what would happen without treatment.

"Pfizer-BioNTech COVID-19 Vaccine EUA", Injection site pain, Severe tiredness, mild headache, muscle pain, fever, loss of appetite, HR in lower 90's, pulse OX in low 90's.

Received Vaccine on 1/2/2021 at 10AM , at 3PM employee felt itchy, took a nap, and at 8PM she had a circular redden skin rash on her arms, legs, and torso. Temperature: 99 degrees. Employee took Tylenol and Claritin for rash, complained of diarrhea, vomiting, and weakness of both knees within 24 hours all symptoms were gone.

i1/13/21 at about 2;45 pm, I had my second Covid vaccination. had pain on site on left arm 1/14/21 woke up feeling a little tired, went to work. went home early at 1:30 pm, feeling a little chilly. no fever. 1/15/21 in the morning noted pain on Left armpit ( injection site is left arm), pain from left shoulder blade to right shoulder blade. took advil. In the afternoon, about 4:00 pm, noted some swelling and soreness on left armpit. took Advil.. 1/16/21, Called employee health to report this. Advised to take advil and monitor and call pcp if symptoms persists.

Redness, sore, large bump and itching - no change since original symptoms. 3 days later still have a large bump under site given, itching and soreness.

Though I had pain and soreness in the arm after both the shots I am left with a residual weakness and ache in the arm almost a month later. I find I am not able to lift items that I was able to lift last month and there is a lump in my left upper arm that is new as well.

itching of scalp, arms, legs; rash; abdominal hives; facial swelling; difficulty swallowing; swelling back of neck; inj site very sore; fatigue; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK923) , via an unspecified route of administration on 29Dec2020 09:45 at the first single dose at arm left for covid-19 immunisation. Medical history included known allergies: Sulfa. The concomitant drug was unspecified. The patient previously took cipro and experienced drug hypersensitivity. On 29Dec2020, the patient expected side effect of inj site very sore and fatigue for 24 hours. On 06Jan2021 14:00, the patient started with itching of scalp, arms, legs ,rash, and abdominal hives. Proceeded to facial swelling and difficulty swallowing, swelling back of neck, took 50 mg Benadryl w some relief. 630 PM symptoms reoccurred, took another 50 mg Benadryl with no relief. Symptoms intensified to severe swelling of the back of neck with intense pressure base of skull, radiating to top of head. Proceeded to the ER. The patient received Prednisone 50 mg orally and for the 4 days. The outcome of event inj site very sore and fatigue was recovered on 30Dec2020; the outcome of events was recovered.

she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.

I had an immediate reaction to the covid vaccine within 30 seconds after the injection. I felt a warm sensation after the vaccine in my deltoid muscle then felt it go up both my ears, around my head. I then felt the same warm sensation in my abdomen, followed by buzzing of my entire body with light headedness. I could breath, I could talk, but I had an urgency for others around me to know that I wasn?t feeling well and something was not right. I asked my colleagues if someone could take me to the ER for monitoring. They immediately put me in a recliner and elevated my legs. This did not relieve my symptoms and asked to go to the ER. I got to the ER and laid on the stretcher with continued increased buzzing sensation especially in my finger tips and arms. My vital signs were 148/88 and HR 88 (elevated from my normal of 100-120/60-70, HR 60s). The buzzing turned into a sensation in my arms that rumbled erratically. I thought something bad was about to happen and that my blood cells would burst. Then I also felt icy cold in my arms and my gut. Next what happened were teeth chattering shivers. All these symptoms occurred in a matter of minutes. They started an IV, drew blood, gave me Benadryl and ran IV fluids. My vitals did not reflect what I felt inside, but as symptoms let up, my VS returned to normal. As quickly as the symptoms started, they eventually calmed down and I was able to leave the ER in 1.5 hours to go home. I was very scared. The ER doctor thought I had a hyperimmune response to the vaccine.

Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.

adverse affect was on 1/12 and was diagnosed by her PCP with Shingles. Today, 1/20, remains with Shingles, with rash, itchy and pain.

Approximately 9 hours after vaccination, pain in injection arm became much worse, a pain rating of 6 to touch and on abduction. About 11 hours after vaccination, I became increasingly uncomfortable, feeling warm, chills, muscle aches. I could not sleep. 22 hours after vaccination, my temperature was 101 F (did not take it before this time). Temperature waxed on waned from that point (day #2). About 36 hours after the vaccine, my temperature stabilized to normal. 48 hours after the vaccine, I felt better and better with each hour.

I developed mild itching of my right forearm and abdomen at 2100 but about 2300 I awoke with severe itching from my head to my hips--no rash. 1 Benadryl did not help, so about another 1.5 hrs later I took another Benadryl and that made the itching tolerable. Having taken 50mg Benadryl I was not able to work at 0430 the next morning as scheduled. The itching continued even with Benadryl every 8 hrs until mid-morning of 12/30. I got the 2nd dose 1/20 & --per the advise of my GP premedicated with 50mg Benadryl, 20mg Pepcid, and 1000mg Tylenol 45 min before the 2nd dose; then I repeated 25 mg Benadryl at bedtime. I developed itching again about 8 hrs later but it resolved by the next morning and was not as intense as with the first dose.

Patient was vaccinated at work on 1/16/21 and developed rash the morning of 1/18/21. It started on the neck / chest and gradually spread to abdomen, back, and extremities. She took Benadryl on 1/20/21 with mild improvement. Rash is described as pruritic. Patient reported to clinic on 1/21/21. At that time rash was present on the neck, back, chest, and lower extremities. Appearance was pink, 1 cm discrete wheals with areas of coalescence especially on neck where it was more excoriated. Patient was treated with prednisone, topical steroid cream, and hydroxyzine. Treatment response is unknown at this time.

I was at work yesterday morning and began to feel shaky. Progressed to both hands trembling; legs feeling weak and wobbly. Could not perform my work duties. Progressed to Rigors. Lasted at least 3 hrs in it's severest form. Now, 24 hrs later I still have some hand tremors, and legs are weak. Shoulder, knees, hips achy. I'm very fatigued. Right arm soreness @ injection site. All events were reported. I was sent home from work, had to be driven home. I rested, slept and hydrated the remainder of the day. Did not go to work today.

Rash in my chest, under my breast and some in the side. Experience some tingling, itching in my legs.

Extremely lethargic Swelling in vaccinated arm Pain in vaccinated arm Body aches Headache Congestion

Extreme soreness at injection site. Impacts ROM. Painful to lift left arm above head. Pain starts below the left AC and extends up to the acromion process. Intermittent relief when taking OTC pain medications.

AT VACCINE SITE R ARM - REDNESS, SLIGHTLY SWOLLEN, TENDER. ALSO C/O H/A SINCE 1500 1/26/21. NOTED CHILLS 1/26/21 PM ALSO

felt cold and chilly; can't move her arm up and down; Fever/ 101.2; body aches; mild pain in arm; This is a spontaneous report from a contactable consumer report self. This 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL4176), via an unspecified route of administration at left arm on 12Jan2021 14:30 at single dose for covid-19 immunization. Medical history included COVID in Nov2020 (Patient was tested for Covid on 23Nov2020 and found out the 25Nov2020 the result was positive), she just quarantined herself at a hotel (They gave her Benzonatate, but she was also taking Tylenol 500mg and Robitussin DM). Concomitant medications not reported. Patient did not get any other shots or 4 weeks prior. No problems with vaccines in past that she can remember. No additional vaccines administered on same date of the Pfizer suspect. Patient received the Pfizer BioNtech vaccine on 12Jan2021 and after that on 12Jan2021 night she didn't feel anything but mild pain in arm, it was so painful, but not as bad on 13Jan2021 even though she still has it. She can't move her arm up and down. On 13Jan2021 morning at dawn she had a fever and it is now 101.2. Has taken Tylenol 500mg (Lot number: SLA071, UPC number: 30047112, Expiry Date: Aug2024). Patient had body aches started 12Jan2021 at midnight (12:00) that is start date of 13Jan2021. She felt cold and chilly and not sure if it was the weather or her. No Emergency Room or Physician Office visit. The outcome of "felt cold and chilly" was unknown, of else events was not recovered.

My eye is swollen, I have knots on my forehead over my right eye. I thought it was a spider bite but now I am not sure

day after shot. Woke up at 3:00 Am with severe pain in my right arm with redness and swelling around the shot area.

in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

(This is a duplicate entry. I mistakenly entered that patient received the Moderna vaccine, but she in fact received the Pfizer.) I got the 2nd dose of the Pfizer vaccine late last Wednesday afternoon (1/20). Before the 2nd dose, I premedicated (as instructed by my medical office) with Benadryl 50mg and Pepcid 20mg (for the histamine blocking effect) since I had terrible itching for about 36 hrs after the 1st dose; but the itching didn't begin-after the 1st dose-until about 8hrs after the shot & became intense 2 more hrs later. I had itching the night of the 2nd dose that kept me awake part of the night but was FAR less intense than after the 1st dose. I came to work Thurs not feeling ill--just cold and tired all day (I attributed to the cold weather and not sleeping well). Thurs about noon I began feeling ill--like I was coming down with the flu; I went home after my shift and found my temp to be 100.4. Shortly thereafter it was 100.9. I thought it would pass by morning so I just showered, drank fluids, took Tylenol and slept. By 0200ish Fri 1/22 I still had a fever of 100.9 (even with Tylenol on board), a bad headache, sinus congestion, and significant neck and back pain so I called out for work. I continued to treat the fever and by noon Fri the fever finally had resolved-along with the head, neck and back pain. I've been fine since.

Began with pain to injection the same evening of injection on Sat 1/23/21, then 2 days later on Mon 1/25/21 with some redness around injection, no drainage or fevers.

exhaustion; Chills; feeling feverish; aching left arm at injection site; This is a spontaneous report from a contactable other health professional (HCP). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular on 10Jan2021 at 15:30 on her left arm at a single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing and known penicillin (PCN) allergy. There were no concomitant medications. The patient previously took erythromycin and clindamycin and experienced allergies. The patient received the first dose of BNT162B2 (lot number: EH9899), intramuscularly on left arm on 20Dec2020 at 03:30 PM. The patient experienced chills, feeling feverish, aching left arm at injection site and exhaustion on 15Jan2021 at 16:45. On 16Jan2021, consumer stated, "I recently had the COVID vaccine and it was last Sunday. Is that possible to have a reaction 5 days out?" There was no treatment received for the events. The outcome of the events was not recovered.

I'm not sure if this is related; Was at work in out patient hospital facility and placed a mask on from a new box. I noticed my nose was itching a bit (I'm very sensitive to certain masks and usually air them out) A little while later I had an intense itching / prickly, sensation in my nose and started itching on my face under the mask. I took it off and found a different brand and took some benedryl. Seemed to get some relief and later that evening, I started to itch again including my head and inside ears, face had flushed with hive like rash. This continued throughout the weekend on and off eventually my whole body was randomly itching/tingly. No problems breathing. Took allergy meds and felt good but noticeably annoying. Called our covid info line on Monday and they gave me a few numbers for allergists. Mine retired. Had an appointment Tuesday morning. Dr felt it probably was reaction to mask not vaccine. Did a patch test with a piece of mask and did itch some but had a reaction to the tape that held the piece of mask in place so results not good. Took medrol dose pack and increased allergy meds. Still itching on and off randomly all over body, not as severe Delaying second vaccine by a week or two until this resolves per DR

Sore at injection site (felt like bruise); Sore at injection site (felt like bruise); This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in the right arm on 16Jan2021 15:45 at a single dose for COVID-19 immunization. Medical history included asthma/allergies and eggplant/zucchini sensitivity. The patient's concomitant medications were not reported. The patient experienced sore at injection site (felt like bruise) on 17Jan2021 that lasted approximately 36 hrs. The patient was okay by 18Jan2021 afternoon. Outcome of the events was reported as recovered on 18Jan2021. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior vaccination and has not tested for COVID-19 post vaccination.

very sore Painful arm at injection site; Started chilling; ran a fever between 102- 103 degrees; headache; felt nauseous; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration in left arm on 18Jan2021 10:00 at first single dose for COVID-19 immunization. Medical history included high blood pressure (BP) on medication, known allergies: Penicillin (PCN), levaquin, covid-19 on 18Nov2020. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient had a very sore painful arm at injection site, no redness, started chilling and ran a fever between 102- 103 degrees during the night and into the next day. Had headache felt nauseous. Events start date/time: 19Jan2021 02:00 AM. By 6 pm the next day the patient started to feel a little better. The patient tested positive for covid 19 in 18Nov2020. Covid was not tested post vaccination. No treatment was received for the events. Outcome of the events was recovering.

C/O "TINGLING PIN PRICKS" WITH SLIGHT ITCHING SENSATION, NO SOB, NO HEADACHES B/P 136/100 SYMPTOMS SUBSIDED 10 MIN. LATER

FATIGUE, SORENESS AT INJECTION SITE, MUSCLE ACHES, DIZZINESS, LIGHT HEADEDNESS, MUSCLE AND BODY ACHES

Day 1 After - overall body aches Day 2 After- no ill effects until evening - noticed red rash on upper torso (front and some on back) Not itchy. No medical attention sought Day 3 After - rash persists and has spread to entire torso - front (Today is day 3)

Itchy rash on bilateral elbow; This is a spontaneous report from a contactable pharmacist. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via intramuscular route of administration on 08Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Jan2021, the patient experienced itchy rash on bilateral elbow. The patient did not receive any treatment for the reported event. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering.

Rash was reported as worsened.; she has developed a rash all over her face, arm, chest, and belly; The rash is just red, raised, and itchy; The rash is just red, raised, and itchy; This is a spontaneous report from a contactable Nurse (patient). The 61-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EL3248, Expiry Date: 01Apr2021), unknown in right deltoid on 13Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Patient History: No. No allergies. There were no concomitant medications. The Caller, an LPN, reporting on the COVID 19 Vaccine and who explains she had it on 13Jan2021. Starting Friday into the weekend and through today she has developed a rash all over her face, arm, chest, and belly on 18Jan2021. The only thing that she can figure is the injection. She was told to call and report this. There has been no treatment, due to the holiday everything is closed. The rash is just red, raised, and itchy and driving her crazy. It is not anything too terrible, just uncomfortable. Rash was reported as worsened. No visit to emergency room or physician office. The outcome of the event condition aggravated was unknown and was not recovered or the rest events. No follow-up attempts possible. No further information expected.

Redness numbness and tingling in both hands Increases when hands are pointed down improves when lifted above the heart Is lessening but is clearly not listed as a side effect It is improving however is concerning more information and direction needs to be addressed several other coworkers have experienced or went to the ED with the same adverse effect. It is clearly not life threatening but I hope it will not increase with the second dose or continue in the future

woke up at 3 am with itching to her chest and arms; This is a spontaneous report from a contactable other health professional. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231), via an unspecified route of administration in the left arm on 18Jan2021 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included "hypothyroid", HTN (hypertension) and allergy to contrast dyes. The patient has been diagnosed with COVID-19 on an unspecified date prior vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included thyroid (ARMOUR THYROID), silybum marianum (MILK THISTLE), magnesium chloride and unspecified BP medications. The patient previously took tetanus toxoid and experienced allergies. On 19Jan2021, the patient woke up at 3 am with itching to her chest and arms. Patient took generic Zyrtec as treatment to the event. Outcome of event was recovering. The events were considered as non-serious. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Dizziness started about 5 minutes after shot. Nurse had me lay down. Better after 20 minutes. Bad headache started while driving home. Took Tylenol but 24 hours later still have headache. Arm hurts at injection site. Very tired. slept 14 hours and still tired. Temp has been around 99.5 when I've been awake enough to take it.

I am not sure this is what i shoud be filling out - just wanted to report what seemed like pretty bad symptoms on first dose by all info i have found. The actual shot was given by another facility than listed previously. I recieved the first dose of Pfizer at Health Dept . No other location information was provided by them. When i got the shot, a blood vein and possibly a nerve was hit. The nurse did everything properly i think to correct and notify other RN. It caused immediate pain in left fingers and arm felt heavy. That continued for days, but not too bad and injection site itself really was not very sore. My concern was how sick I felt starting within 6 hours of the injection and how long it lasted. I had pretty much instant nausea- no vomiting- mild but persistant, severe fatigue and general overall uneasy/sick feeling. Joint pain started within the 6 hours, along with a few odd pains in neck and right abdomen. Was extremely chilled for hours, pretty bad tension /tight feeling headache, jittery feeling and foggy. I took a 500mg Tylenol about 8 hours after the shot, and it helped to relieve most symptoms to a degree that was nagging, but tolerable. I pretty much went through this for about the next 3 days and off/on to the 5th day

facial flushing for 1 hour after shot. Redness on nose and cheeks for about an hour. No hives, no itching. Didn't notice until I left the vaccine site and was on the way home in car because covered by mask. Note I am a very fair skin, freckled red haired woman. I was very, very nervous and had gotten myself to the point of tears. Perhaps the flushing was from that. Have had similar flushing when drinking red wine. Swelling in lymph node in supraclavicular area on same side as shot. Has happened with Flu shot once. Slight fever for a short period of time and fatigue. I continue to have slight shortness of breath from having covid on. 4/3/20. Nothing different.

Thyroid levels change meds changed to 50 mcg, red dots all over on torso, both back sides left , right. front breast right one , lower stomach area right, left. Emergency room doctor took photographs.

Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough

Slight redness, slight swelling, and rash around the shot site. Applied benadryl cream for the itching. Resolved within 24 hrs.

On February 4, 2021, I started to itch and feel like pins were sticking me on the front of my neck under my chin. On February 5, 2021 I started taking benedryl 25mg to combat the itching. By February 8, I had a fine rash, small raised all around my neck and very itchy and again I took benadryl without improvement. Benadryl would have a short term effect and just made me sleepy. This continued for 3 more days until February 15 when I was able to see my doctor who has now listed me as having a reaction and allergic to the Covid 19 Vaccine. I am prescribed topical steroid cream and hopefully it will improve.

Developed generalized rash over body, more pronounced on knees and lower legs. Rash remains now but is lighter. Significant L knee pain.

Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have

Having pain and burning sensation to skin at injection site of left shoulder. It radiates to the base of the head, posterior left shoulder and upper arm. Took one dose of Excedrin with temporary relief.

Numerous tiny white bumps on both legs only that were somewhat itchy & disappeared completely after 4 days; no treatment given

2/10/21: Woke up with chills, no fever @5:15am, back to sleep, Temp 99.3F at 10:05am, Tylenol at 10:50am, Temp 100.3F at 5:15pm Temp 101.3F at 9:10pm and took tylenol and regular medications, Temp 100.6F at 10:55pm and went to sleep. 2/11/21: woke up with temp 98.7 at 10:00am, had body aches, red and feverish area where vaccine was given in upper left arm. The red, itchy and feverish area about 3 inches x 2 inches on upper left arm lasted about 5 days, also got a lump under left arm that lasted about 6 days and all of these went away by 2/17/21. But I've had more fatigue, and shortness of breath since this 2nd vaccine. Misses my doctor appointment on 2.17/21 due to the winter storm, not going anywhere , we were having all last week.

Right side upper arm ache spread to right side of neck and into headache at back and top of skull. Persisted through night and spread down into right side of neck to left arm ache. Throat became red and right, then left side of tonsil became pus filled. Chills but no fever. Fatigue every day. Took 2-3 hour naps every couple of days and slept 8-10 hours through the nights. Headache off and on for 10 days. Throat remained red, becoming most sore late afternoons, voice hoarse. On and off drippy nose. On the 13th day I felt normal energy level in the morning but today, my 15th day at nearly 3pm, my normal energy is waning and throat becoming sore again.

I don't want to file two reports. I had an episode of feeling very dizzy and when I laid down for an hour and I got up I couldn't remember names of anyone, went to hospital to rule out stroke. EEG and double echo both normal. MRA and MRI, no evidence of stroke, transient global amnesia, it took a couple hours for me to get back to normal. I also had a shingles outbreak 10 days post both vaccines.

Had my 2nd vaccine 1/28/21. On 2/3/28, I has rashes, redness & itchiness upper chest. On 2/5/21, My lymph nodes right neck is swollen, also painful mass around 2x3cm below right clavicle near the sternum. I also have flu-like symptoms, body weakness especially lower extremities. Rashes and itchiness upper chest still present. 2/9/21 : Lymph node swelling of right neck & below right scapula still present. Rashes & itchiness upper chest still present but controlled with hydroxyzine tablet. Flu-like symptoms still present. 2/11/21: Rashes & itchiness minimal, less medication needed. Lymph node swelling less, still gets tired easily. 2/19/21: lymph node below right clavicle bigger for 1 day. No more lymph node swelling right neck. Still gets tired easily. 2/24/2021: Lymph node below right clavicle 1x1 in size, not painful.

Pain on right-side of back all the way to front of chest and under breast and part of right shoulder. Week prior felt sensation of "pins and needles" on back. Patient reports 1 blister spot on chest. Patient went to urgent care and was diagnosed with shingles. Doctor prescribed Valtrex and Ibuprofen.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

About 10 minutes after receiving the vaccine, patient reported feeling somewhat short of breath and itchy. She presented to the clinic somewhat short of breath because of her asthma, but the itching was completely new. Gave the patient an age appropriate dose of Benadryl and symptoms resided within 15-20 additional minutes of observation time.

Eyes bloodshot; Rash over entire body...arms, legs, abdomen, back, neck; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 20Jan2021 07:45 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (WP THYROID), methocarbamol, and paracetamol (TYLENOL). The patient has known allergies to cefalexin (KEFLEX) and statins. The patient was previously vaccinated with the first dose of BNT162B2 on 06Jan2021 07:45 at the age of 61-year-old intramuscular at the right arm for COVID-19 immunization. The patient experiences rash over entire body, arms, legs, abdomen, back, neck, not on the face yet and eyes bloodshot; symptoms appeared over 8-hour period beginning at 7 am on 26Jan2021. The patient did not receive any treatment for the events. The outcome of the events rash over entire body and eye bloodshot were not recovered.

Localized rash; High fever; Nausea; Vomiting; Dizziness; Rapid heart rate; it was after the shot, if she pressed where the injection was it is still a little sore; She called in sick last week; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiration date not provided), via an unspecified route of administration in the right arm on 19Jan2021 13:30 at a single dose for COVID-19 vaccination. Medical history included Blood pressure high diagnosed a couple years ago. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) for COVID-19 immunization on 29Dec2020 and unspecified flu shot last fall, she thinks in Sep or Oct2020, but she has never had problems with those. Concomitant medications included unspecified medications. The patient called and said she had reaction to the Pfizer COVID-19 vaccine 12 hours after her second dose and wanted to report it. She said also this past weekend, on Sunday, on 24Jan2021, she started to develop a localized rash that has like a border to it. She added that she got her second dose of the COVID-19 vaccine on 19Jan2021 at about 01:30 PM in her right arm. She said that she woke up the next morning, 20Jan2021 at 03:00 AM with a high fever, nausea, vomiting, dizziness, and rapid heart rate. She said that the high fever that started the temperature she took was 103 initially, she says she took paracetamol (TYLENOL) and it came down to 101, and the next day it was probably 100 most of the day, then it broke that evening. She said the Tylenol, the dose was the extra strength, unknown if it was 500 mg, they were capsules. She says she normally doesn't keep it around, the in-house nurse suggested it so she went and got a sample thing and took a couple doses, she doesn't have it with her as she is at work and is not at home. She said that the nausea and vomiting subsided after the first day or second day, she had the on and off fever and slept most of the day both days. She said that she doesn't have a fever now. She said that she doesn't have her exact heart rate from when she was having the rapid heart rate, she just felt it in her chest. She added that the only reason she said anything was because she called in sick last week on an unspecified date in Jan2021. She said that the rash started developing after that and it is now probably the size of a 16 oz or 60 oz cup, unable to clarify number with caller, she said that it is definitely big but it doesn't bother her, though she is concerned it is there. She clarified that it is a couple inches in diameter and kind of looks like the state of (State Name), on her injection arm which was her right arm. She said her arm is not sore now, it was after the shot on an unspecified date in Jan2021, if she pressed where the injection was it is still a little sore. She said that the hospital said to report it. She said she also has a concern if she should she get another shot if they decide this is needed for more than two vaccinations. She said that she knows they are still gathering information at this point, so she thought she should better turn in, hopefully there will be solution later on. The outcome of the events localized rash, dizziness, heart rate increased and sickness was unknown. The outcome of the events fever, nausea and vomiting was recovered on an unspecified date in Jan2021 while the outcome of the event vaccination site pain is recovering.

Fever, chills, body aches, nausea, pain at injection site, extreme fatigue, headache. Also on 2/8 had a Shingles rash for which I consulted a dr and was treated

Severe neck soreness and tenderness 2/27 & 28, took Tylenol Rash& Itching at injection area. 2/27 4:00pm. Itching stopped 2/28 however the rash is still present on 3/2. Took Benadryl.

rash on neck; felt a little off, it could have been in her head or maybe was paranoid, but wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL; developed a bad rash, hives, all over her body; developed a bad rash, hives, all over her body; itching; a few bumps kept increasing up to 3 days later; her feet were incredibly hot over the next 3 days; arm soreness; She was unable to sleep from being so itchy; Allergic reaction; This is a spontaneous report from a contactable consumer herself. A 61-year-old female patient received bnt162b2 (, Solution for injection, Batch/lot no: EN5318), via an unspecified route of administration on 04Feb2021 15:00 in the left arm at single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously did get a flu shot in Nov or Dec2020. The patient developed a bad rash, hives, all over her body and itching on 10Feb2021. She reports, her feet were incredibly hot over the next 3 days on 07Feb2021. What started off as a few bumps kept increasing up to 3 days later. She was unable to sleep from being so itchy. Her doctor said it was an allergic reaction and prescribed an antihistamine after which it left in Feb2021. She was due for the 2nd dose of the vaccine on 25Feb2021. The patient did not had any investigation assessment. The patient states that there was little information out there to compare the experience she had. Wanted to call to make Pfizer aware of that and maybe get some more information out there. Has printed out the fact sheet and assumes she should not get the second vaccine because of what happened the first time. Wants to clarify what happened and share with Pfizer this information since she can't find much information for people who have had a delayed reaction. Went to get the vaccine on 04Feb and doesn't consider herself an allergic type person. Has no allergy to foods, medicines, only gets poison ivy and bug bites like most people. By Monday, the 4th day (08Feb2021) after getting the vaccine, noticed a couple of bumps on the wrist and does not know where else and didn't think of it as anything else. Thought it was a bite or she touched a plant and then it went away. It was not much. In the evening of Tuesday she had a bad reaction and on the 10th (10Feb2021) she had rash, hives, and itching that just moved to different places over the body. Her feet were so hot on the 3rd day and had to plunged them into cold water and used Epsom salt off and on and it helped some. This happened only for 2 nights and the reason she didn't go to the doctor, it went away. Again, mentions the first night she had a couple bumps and didn't think much about it. The second night, it was all over her body, the rash, and she took Epsom baths that helped, but she didn't get much more than an hour of sleep. She tried to take pictures of her thighs and backside, but unable to take good pictures, not a selfie person. The next morning she had her husband take pictures in case it went away and she went to the doctor they would have pictures to show. Her husband thought it may be shingles. Called the doctor on Thursday and had pictures to show her since the rash went away. Again, mentions the reaction was so bad on Wednesday. The doctor didn't believe areas on pictures of her back were shingles since shingles does not come and go away like that and that she must have had an allergic reaction to something. Provider didn't believe it was from the vaccine. Was given a prescription for Hydroxyzine HCL 25mg and was informed if areas didn't improve or returned she may need to see an allergist or immunologist. After the appointment she didn't get much sleep and woke up at 4pm in the afternoon and felt a little off, it could have been in her head or maybe she was paranoid, but she wasn't going to wait for the reaction to be full blown over her body and took one Hydroxyzine HCL and went to bed at 7:30pm and didn't do anything since. Got up and the reaction/rash, hives, itching was all gone after taking only one. It's like an antihistamine or Zyrtec. No further details provided. Later mentions after getting the first vaccine on the 4th, the next day she had arm soreness up until that Monday when the rash started. No further details provided. Says as far as recommendations were concerned for the paper she printed, the fact sheet. It says pretty much listed, she shouldn't have the second dose if difficulty breathing, swelling in the face and throat. The only thing she had was the rash on the neck, not the face. Paperwork also lists heart beating fast, or severe allergic reaction. The patient had no emergency room visit. The patient visited the physician office. The outcome of the event hot feeling in feet was recovered on feb2021 and rest of the events was recovering.

numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!

At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt it swell. I looked in the mirror and could see the left lower part of my face (lower cheek by the edge of my mouth) swell and my right upper lip started to swell. I took a Benadryl (25mg oral tablet) and my roommate drove me to the Emergency Room. That area of my face continued to swell and impacted my lower lip as well. My lips were numb and tingling and I could feel my cheek swell more inside my mouth as it was touching my teeth. I was monitored (vital signs and pulse ox) for 90 minutes and received 20 mg of pepcid oral tablet and 10 mg dexamethasone oral tablet- both 1x only.

arm soreness at injection site (both vaccines); fever <100.6F x 24 hours; delayed headache x 3 days; enlarged left breast lymph nodes; This is a spontaneous report from a contactable health care professional (patient) reported for herself. A 61-year-old non-pregnant female patient (Patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL0140, expiry date: unknown) via an Intramuscular on 28Dec2020 at 12:00 PM (at the age of 61-years-old) on Left arm at single dose and second dose (lot number; EL0142, expiry date: unknown) via an intramuscular route on 19Jan2021, at 08:30 AM on left arm at single dose; both for COVID-19 immunization. Medical history included hypothyroidism and hyperlipidemia. Patient received unspecified concomitant medications (Other medications the patient received within 2 weeks of vaccination (unspecified)). Patient had no Allergies to medications, food, or other products. On an unknown date, the patient had arm soreness at injection site (both vaccines); on 20Jan2021, at 05:00 am, patient had fever less than 100.6 F x 24 hours, delayed headache x 3 days for 3 days, enlarged left breast lymph nodes (routine mammogram/sonogram was 2 days post injecting on left arm). No treatment was received for the adverse events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 25Jan2021, patient underwent nasal swab (SARS-COV-2-BY-NAAT) test and resulted as negative. Seriousness of the events was reported as non-serious. Outcome of the events was recovered on an unknown date in Jan2021.

Hives on back of neck. Slightly itchy. Noticed a couple hours after vaccine. Noticed a bit more the next morning. Took Benadryl 3/7 night. No increase or decrease in hives noticed so far.

I felt a shooting pain immediately from my arm into my shoulder area, and then felt itching and had a slight rash on chest area. When checked to be released, upon mentioning the rash, they checked my blood pressure, which is normally in the 90-100/68-70 range (low!) and it was 138/80. Sounds normal, but I?ve never had a blood pressure reading that high! I felt ok enough to leave with my husband, but later got dizzy, nauseous and throughout the day my joints (neck, shoulders, arms and legs) got increasingly painful, to the point where I could barely climb the stairs that night without assistance. Note: I run 5K every other day and bike or walk on off days, so I?m pretty active. I took Tylenol and went to bed early and was stiff, but better the next morning. Made myself get outside for a light run and was basically fine (albeit very tired) the next day. First day was a little scary though.

After 1st dose : Fatigue/tiredness/lack of energy for 1 day. After 2nd dose: Fever of 101 - 102.6 for 3 days. Hips achy. I have a total knee replacement of my R knee. That became warm to touch, painful and very stiff. The knee surgery was 3 years ago. I was prescribed MOBIC for the knee by my surgeon when I reported the issue.

I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.

He received his 1st COVID-19 vaccine around January 24th and 30 minutes later developed mild lip edema, itching of the skin Nose and ears. A day after injection patient had Benign fasciculations

Received Pfizer vaccine at the Hospital on March 12, 2021 at 10:05 a.m. No reaction at that time. One hour later my ears and scalp began to itch. I had chills and severe nausea. Severe stomach cramping. Rash covering arms, legs, scalp, back and shoulders, Hives across chest and down both arms. Swelling and hives on palms of hands. Difficulty breathing. Symptoms began one hour after vaccine and continued to worsen. Was treated at Center for allergic reaction. Was given Benedryl and Famotadine, then released.

Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.

One week after receiving the vaccine, my arm began to swell at the injection site. Today it?s larger, about the size of a tennis ball and it?s warm to the touch. It?s also a little red. It does not hurt.

Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: itchiness at site of injection, mild

8 days after vaccine, developed burning sensation of skin which has changed locations in upper and lower extremities. Lasts hours at a time and changes location. Also developed diarrhea, vomiting, body aches, chills 8 days after the vaccine.

Developed a rash near my eye after a couple of days rash moved to my face and neck. After the second shot rash covered face, neck and face and eyes would be swollen

Friday evening I was tired and slept a lot. When I woke up on saturday I had pain in my muscles and neck and in my shoulders. I was not hungry and I had a fever(101.2). I slept until 1pm and I started getting nauseous. I never got up off the couch saturday. Pain in left arm/shoulder blade went away around 5pm Saturday. I still had a slight fever and headache saturday evening. Sunday I felt better but I still had a slight fever and headache but felt generally much better. Monday I had no fever no headache, and a little aching in my right arm at the injection site.

Had severe headache, chills, fever, whole body aches, joint pain, swollen arm, very hard lump and hot at injection site. All this started the day after injection .so severe that it felt like I had covid AGAIN! Couldnt eat or hardly get out of bed the day after shot and the second day after the shot I still felt the same but was able to eat . The third day after shot, my fever went away and most of the body aches except I still have the headache and my arm is still hot, and swollen. Just have been taking tylenol this whole time and cold wash cloth for fever and swelling.

Pfizer-BioNTech COVID-19 Vaccine EUA. injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell

Patient was sitting in monitoring area status post covid vaccine injection (Pfizer 0.3mL). Patient complained of flushing, erythema noted on anterior neck and chest, and hive was observed. Patient denied shortness of breath. BP 132/92, HR 90, Pulse ox 98% room air. Benadryl (Lot #080012, exp. 08/2022) was administered 50 mg/IM per order into left deltoid @ 1337. EMS was called per protocol. 1340- Vital signs were 156/110, HR 84, pulse ox 98%. 1342- EMS arrived- VS 162/110, HR 85, pulse ox 98%. Patient then complained of feeling lightheaded. Patient was transported to ED without further incident

Swelling/pain in Left deltoid at injection site; Mild frontal headache; Fatigue 4 hours after vaccine Mild frontal headache; Swelling/pain in Left deltoid at injection site; This is a spontaneous report from a contactable nurse (patient). A 61-year-old non-pregnant female patient received BNT162B2 (solution for injection; lot number: EL9264) in left arm, via an unspecified route of administration on 09Feb2021 09:30 am at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history included osteopenia, mild depression. The patient had no known drug allergies. The patient concomitant medications included citalopram, ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+). The patient was not diagnosed with covid-19 before vaccination and covid was not tested post vaccination. The patient experienced Swelling/ pain Left deltoid at injection site, fatigue 4 hours after vaccine, mild frontal headache on 09Feb2021 13:00. The patient did not receive treatment for the events. Outcome of vaccination site swelling and pain was recovered on an unspecified date of 2021 and rest of the events was unknown.

Within minutes of getting the shot in my left arm I started to feel the left side of my neck getting stiff. It felt like the stiffness was creeping up my neck. After about a hour I felt my ear lobes tingling and the left side of my face in the jaw area seemed a bit swollen and felt a little numb. It resolved and I had only a sore injection site the next day and no other symptoms. I'm wondering if I should be concerned about getting the second shot

nausea; chills; diarrhea; bad chest pain could barely breathe; bad chest pain could barely breathe; left arm where the injection was given was very painful from the injection site to her wrist and; left arm where the injection was given was very painful from the injection site to her wrist and; can barely lift her arm over her head; increase in her blood sugar; arm pain; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient, not pregnant, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265), via an unspecified route of administration in the left arm, on 02Feb2021 14:30, at a single dose, for covid-19 immunization. Medical history included diabetes, high blood pressure, and sciatica. Concomitant medications included insulin glargine (LANTUS); metformin; hydrochlorothiazide; candesartan; glipizide (GLIPIZIDE XL) and; colecalciferol (VITAMIN D [COLECALCIFEROL]) - all taken for unspecified indications with start and stop dates not reported. The patient previously received sitagliptin (JANUVIA) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient did not have Covid prior vaccination. The patient received the vaccine in a public health clinic/veterans administration facility. The patient received the Pfizer vaccine dose 1 on 02Feb2021. The patient experienced nausea, chills, diarrhea and bad chest pain could barely breathe - these have passed. Her left arm where the injection was given was very painful from the injection site to her wrist and she has been alternating ice pack/heat pad and taking Tylenol 650 mg for the pain. She can barely lift her arm over her head. She also noticed an increase in her blood sugar and her blood was really dark - she stated this was unusual. She asked if there was anything she can do or take that might decrease her arm pain. All the adverse events happened on Feb2021 and resulted in doctor or other healthcare professional office/clinic visit. It was reported that the patient had not recovered from all the adverse events at the time of the report. No treatment was received for all the adverse events, except for "left arm where the injection was given was very painful from the injection site to her wrist" (alternating ice pack/heat pad and taking Tylenol 650 mg for the pain). The patient has not been Covid-tested post vaccination.

Developed skin rash within hours of receiving vaccine, started on the forehead and spread down the face including the ears and eyelids, a more mild rash on the arms, legs and stomach. took some Benadryl which help with the rash. rash lasted about 4 to 5 days.

Large raised red area at injection site started the day after injection and it has now been 8 days and it is still there and itching and warm to touch

bruise to her back; rash on back of neck/rash all over her body; redness; swollen area back of neck/ swollen area to her back; a lot itchier; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via intramuscular on left deltoid on 21Jan2021 at 14:00 at single dose to prevent Covid 19. The relevant medical history included obese from an unspecified date. Concomitant medications were reported as none. The patient experienced rash on back of neck/rash all over her body on 26Jan2021 at 19:30, swollen area back of neck/ swollen area to her back on 26Jan2021 at 10:00, redness on 26Jan2021 at 19:30, bruise to her back on 27Jan2021 at 10:00, a lot itchier in Jan2021. The nurse stated that she wanted to report that she had the Pfizer vaccine last Thursday. Stated that two days prior to the report that a rash started on the back of her neck and stated yesterday it was a lot itchier (as reported). Stated that she got undressed to put her PJs on and noticed that she had a fine raised rash everywhere and it was swollen. Stated that she went through her house to see if there was anything that could have caused it. Stated that she went to that doctor at the time of the report and was started on Prednisone taper. Stated that the doctor was concerned about the Prednisone reducing her ability to prevent antibodies. Stated that the doctor stated that he was unsure if she should get the second dose. Caller wanted to ask questions about these things. Had not started the Prednisone yet. Stated that there was redness to the back of her neck and back. Stated that the swelling was to the back of her neck and back. The events did not require a visit to Emergency Room but required a visit to Physician Office. Prior Vaccinations (within 4 weeks), no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The event bruise to her back was reported as non-serious, while the events rash on back of neck/rash all over her body, swollen area back of neck/ swollen area to her back and redness were reported as serious due to medically significant. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "rash on back of neck/rash all over her body", "swollen area back of neck/ swollen area to her back and redness" and the administration of the COVID-19 vaccine, BNT162B2, based on the plausible temporal association and lacking alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.

Immeditely after my first shot on March 7 I felt fine (except some mild soreness at injection site). A full week later, on March 14, I had some mild chills, fatigue, headache, and a red itchy rash. The rash was located on my right inner forearm, my left inner thigh, my lower back and hip area, and my ears. No rash on injextion site arm. I took benadryl and used a topical 1% hydrocortisone cream, and the rash eventually subsided after 5 days.

I woke up at 2:30am morning of March 19, 2021 with fever, chills, severe headache, throbbing arm pain in left arm from shoulder to elbow (injection was in left arm), and nausea. Got up to try to get Tylenol tablets, but returned to bed because I was unsteady on my feet & didn't feel like I should try to go downstairs to get the Tylenol or a thermometer to take my temperature. But my husband said I was warm to touch when he brought me extra blankets to help mitigate persistent chills I was having t/o the night. Symptoms continued until morning of March 20, 2021 and gradually lessened by evening. Stayed in bed all of March 19th and took Tylenol 650mg every 6 hours to lessen bad headache. Ate a few saltine crackers to lessen nausea symptoms & drank ice water. Had a small nosebleed evening of Mar 19th that resolved with pressure to the bridge of my nose. Today (Mar 20th), I have residual light headache that goes away with Tylenol, but no fever, chills, nosebleeds or arm pain.

A very itchy rash which looked like shingles about 5 inches in diameter appeared under my right arm close to my breast on Sat. About 30 mins. later it began to look like large welts. About 30 mins. after that it disappeared leaving raised skin. The raised skin went away in about 30 mins.

After taking a hot bath. Redness at vaccine site and down the left arm on both sides. Some itchiness at the vaccine site. Took 1 benadryl and the redness and itchiness disappeared rather quickly. Some mild redness at the site.

Patient received the Covid-19 vaccine. She reports symptoms of sudden onset itching throughout entire body 5 minutes post-injection along with sudden onset severe headache. Vaccine injection time 1715, symptom onset at 1720. Vitals: @1720: BP 148/94, HR 79, O2 98 @1725: BP 148/83, HR 80, O2 99 (PO benadryl 50mg given at this time) @1730: BP147/80, HR 70, O2 96 @1735: BP 148/82, HR 71, O2 99 @1745: 149/92, HR 74, O2 98 @1755: BP 148/71, HR 73, O2 97 @1805: patient ambulated to restroom. Patient stated that "symptoms aren't improving at all after benadryl -- I think I should go to the emergency room. Wait until I get back from the bathroom to call 911." @1814: Patient returned from restroom, 911 called @1820: EMS arrived, care handed off to EMS @1825: EMS transported patient to ER

Patient stated that approx. 5mins after getting the vaccine, she felt very nauseous and had full body itchiness. 50mg of PO Benadryl was given prior to coming to the hospital. Patient arrived at hospital & still complained of itchiness. Pt received solumedrol & Pepcid IV.

On 3/19/2021 around 4:00 I started with body aches, headache, fever, and chilling. I continued with that during the night and on 3/20/2021 I still had the body aches and felt weak. On 3/21/2021 I noticed that I had a rash developing in places. On 3/22/2021 I woke at 5:00 a.m. covered with a rash over my entire body that itched. I took Benadryl and that is when I went to the ER.

Rash on my abdomen and arms started about 5 days after the vaccine. Rash is itchy and looks like raised bug bites. Itching mostly at night. Will break out in different areas on arms from day to day. Abdominal rash remains constant. Started using OTC cortisone to minimize the itch and started taking Zyrtec for the itch. It still remains as of this report and hasn't gotten any better.

Sore arm at injection site with both shots. With the second shot only: Next day @ Approximately 7:00 am started feeling dizzy. Approximately noon stated feeling chills and general body aches. 6:00 pm took ibuprofen and slept until 6:00 am next day . All symptoms then gone

very large red rash at the injection site; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL9265), via an unspecified route of administration in the left arm on 29Jan2021 1:00 PM a single dose for COVID-19 immunisation. The vaccine was administered at a hospital. The patient did not receive any other vaccines in four weeks prior to receiving BNT162B2. The patient was not pregnant. Medical history included seizure disorder. The patient did not have covid prior to vaccination. She had no known allergies. On 06Feb2021, the patient had a very large red rash at the injection site 8 days after vaccination. It was not particularly itchy or uncomfortable. It seemed notable only because it was over a week later. The patient did not receive any corrective treatment for the event. Outcome of the event was recovered on an unspecified date. The patient was not tested for covid post vaccination.

Around 11, 11:30 the pain woke me up because it was so bad. It was hot and there was a big lump under my left arm pit (was very tender). I did not go to sleep like that. I did not have any symptoms by the time I went to bed. I also felt hot, and then cold, then hot, then cold, I would feel too hot and then too cold, freezing, I could not keep my temperature under control. I had to call in at work during the weekend I was feeling so bad. I had a lump under my armpit the size of a fist and I could not close my arm completely. It was huge and painful. I decided to go to a clinic over the weekend (unsure if Saturday or Sunday) to seek medical care and they ran some labs and a CBC to check for infection. All results came well no infection. They suggest to keep taking Tylenol. By Monday or Tuesday I started feeling well enough to return to work. The lump was still present and took about a week to go down. The injection site also was sore for a while, about a week also like the lump.

Low fever (100 F), pain at injection site, nausea and dizziness. It lasted about 12 hours. I took a Tylenol when nausea subsided (in the afternoon).

Pfizer-BioNTech Covid 19 vaccine The night of the vaccine March 11th , I had fever of 100.8, chills, headache, muscle aches, sore throat, joint pain that lasted until Tuesday morning, March 16th. I had no symptoms on Tuesday & Wednesday, but developed hives on my ankles Thursday afternoon exactly one week after the Covid 19 vaccine. When I got up Friday morning I was covered in hives on my legs, arms and abdomen. The whelps were raised and itchy and appeared to be spreading. I went to my HCP and they administered an intramuscular steroid shot and advised me to take Benadryl as needed

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

I started developing painful nodules upper neck(right), around outside ear(sright) lower jaw line. Being a nurse I thought I was breaking out as the days went by I noticed it was Shingles.

Patient received vaccine Saturday morning 3/20/21. She stated she woke up on Sunday morning 3/21/21 and had a "rash on her arms and chest, and some of the spots looked like blisters." She went to her dermatologist on Wednesday 3/24/21, but they did not give her medication for treatment. Patient states that the rash is improving.

Huge bruise with a knot. Warm to touchArm pain to the point I couldn?t lay on it. Side effect symptoms started 3 days after injection on 03/24/2021. Headache, chills, fatigue, atypical chest pain.

Patient expressed anxiety. Had same symptoms with flue vaccine in 10/2020. Left arm injection site no redness, warmth. Patient expressed both parents recently passed away and expressed increased anxiety. Pt walked to the car, steady and stable. Pt will take tylenol as prescribed, rest, and hydrate. Recommend pt to follow-up with PCP on Monday for anxiety and elevated BPs. Pt denied HTN. Vitals: At 13:25, 160/82. 1 minute after 99 At 13:45, 160/82, 98HR, 99% spo2.

Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, trunk, under hair on head, and partially down back of neck.Severe itchiness. Took OTC benadryl, two tablets, no relief. 3/27 rash continues, itches more in evening

Beginning around 8:00 pm I felt prickly all over my body. Not severe, but uncomfortable. I believe I also developed a minor rash. I took benadryl that night and slept fine. I felt the same way on 3/23/21 and took benedryl again. It seemed better 3/24/21 but came back on 3/25/21 and has continued today 3/27/21. After a walk outside with no jacket it is feeling better, but I can tell it's still there. Called my doctor on 3/23/21 and she recommended benadryl at night and allegra or claritin during the day. And ibuprofen and pepcid. I only have taken the benadryl. She advised not getting the second shot.

Complaint of itching beginning on face and all over body within 25 minutes of receiving vaccine. Hive-like rash to back present. Patient was given Benadryl 50 mg IM per Nurse Practitioner order and symptoms began to resolve within 10 minute with complete resolution within 30 minutes. Patient left clinic with family member and was advised to contact emergency care or physician if symptoms return.

Pfizer COVID-19 Vaccine EUA Patient presents 3/23/21 for medical monitoring of syncopal episode s/p COVID - 19 vaccine # 2. Lowered to the floor by vaccine staff. Patient reports symptoms of weakness, other wise states she ""feels fine"". Two additional syncopal episodes witnessed by myself when patient attempts to change position. Past medical history is significant for mild persistent allergic asthma, pre-diabetes, OSA, obesity and BPPV. Patient reports history of same reaction s/p previous vaccine. At a approximately 0837 patient was noted to have a worsening rash present to her face. EpiPen administered via left lateral thigh at 0838. EMS called to transport patient the ED for further evaluation. Treatment administered: epipen (lot 0FM406, exp 02/22) left lateral thigh at 0838. Upon arrival to the ED, patient's temperature is 98.8° F, heart rate 92-103, respiratory rate 30, saturating 99% on room air with blood pressure 164/91. The patient's laboratory studies were largely unremarkable. While in the ED, the nurse was getting ready to get the patient up to the commode when the patient started to ""not feel right again."" She asked her to administer the medications for allergic reaction and reports wall the 2nd medication was being infused, she felt paralyzed and unable to talk, although she was able to hear everything and was aware, she was unable to move or speak for a short amount of time. CT head with completed at this time and showed no acute intracranial findings. Chest x-ray unremarkable. EKG showed normal sinus rhythm with sinus arrhythmia, heart rate 80 and prolonged QT at 470. The patient was administered Solu-Medrol 125 mg IV, Pepcid 20 mg IV, Benadryl 50 mg IV, normal saline 1 L IV. Pt was admitted to hospital for observation. The patient was seen on the unit laying in bed with her husband at the bedside. She reports that she is feeling slightly better and hungry and has never felt at paralyzed/unable to speak feeling before and is very nervous about this. She was wondering if she had a seizure, although she reports feeling aware the entire time and did not lose bowel or bladder function. We discussed that that is not typical for a seizure, but even if we did an EEG at this time, it would not be able to tell us what occurred in the past. We discussed continue the Benadryl, Pepcid, and IV steroids for today and likely decreasing them tomorrow. We discussed the workup of syncopal episodes as well. The patient and her husband were agreeable to this plan. Patient was discharged from the hospital on 03/24/2021 in a stable medical condition. Patient was instructed to follow-up with her PCP in 1 week.

Pfizer-BioNTech COVID-19 Vaccine EUA The area received vaccination was sore, about two hours later became drowsy, had to leave work and go home, woke up around 5 p.m. body ached on left and right side, took Aleve for pain.. Overnight had chills, headache, next morning, took Aleve for pain. Whole body ached for about a week, headaches, lethargic, tiredness. About week and half later only ache in right arm, sore like I sprained it, still tender today.

Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to the nostril shot of Flonase

Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my throat felt odd and was accompanied by a hoarse voice. I was driving home at that point and considered turning back for medical advice (should have but did not). Over the next few hours itching sensation on my tongue, face including eyes, head and back. Developed just one hive on my eyebrow approx 3 hours after vaccination, and one on my thigh at least six hours after vaccination. The symptoms were not severe but obviously I monitored them. Now 24 hours after the vaccination and still have some itching as described above. Throat is somewhat better. Eyes feel odd more than itchy at this point.

Injection site pain and redness, tiredness, splitting headache, muscle ache, chills, joint pain, intermittent fever, loss of appetite

Hit with heaviness limbs; whelps all over body arms legs stomach back groin; pain in joints; felt like fire ants; chills; no energy; tightness in chest; This is a spontaneous report from a consumer reported for herself. An 61-year-old female non- pregnant is unknown female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198), via an unspecified route of administration on Left arm on 02Feb2021 17:45 at single dose for covid-19 immunisation. Medical history included COVID-19, Congested Heart disease, and Penicillin allergy. The patient's concomitant medications were not reported. The patient experienced Hit with heaviness limbs pain in joints whelps all over body arms legs stomach back groin felt like fire ants chills no energy tightness in chest on 22Feb2021. Received Inhalers for breathing and steroids. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Recovering".

pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine. Facial muscel spasms; both eyes and left side of cheek area. Never had this before.

Body aches; Sore injection site; Nausea; This is a spontaneous report from a contactable consumer. A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administered in Arm Right on 09Feb2021 15:30 as Single Dose for covid-19 immunisation. Medical history included drug hypersensitivity (Sulfa allergy), thyroid disorder and hypertension from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, liothyronine (NP THYROID) from unspecified date to unspecified date for unknown indication. On 09Feb2021 23:00, The patient experienced body aches, sore injection site and nausea. The action taken in response to the events for BNT162B2 was not applicable. Outcome of events was not recovered.

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

Fatigue; Fever (101.6); Chills; Shakes; Muscle pain; Joint pain; Headache; Foggy head; Loss of appetite; Nausea; Sore arm at injection site (minor); Swollen lymph gland under left arm; Dizzy; This is a spontaneous report received from a contactable nurse (reported for herself). A 61-year-old female patient received second dose of BNT162B2 (Comirnaty, Solution for injection and Lot number: EL3246), intramuscularly to left arm on 12Jan2021 10:00 at a single dose for COVID-19 Immunization. Patient medical history was reported as none. Patient concomitant medications included calcium, ergocalciferol (VITAMIN D), multivitamin and probiotic. The patient previously took BNT162B2 (Comirnaty, Lot number: EJ1685) vaccination, intramuscularly to left arm on 22Dec2020 for COVID-19 immunization. On 12Jan2021 22:00, 12 hours after the second dose of vaccination the patient experienced with fatigue, fever (101.6), chills, shakes, muscle pain, joint pain, headache, foggy head, loss of appetite, nausea, sore arm at injection site (minor), swollen lymph gland under left arm. patient was on bed and felt dizzy after fever broke for about 24 hours. Seriousness was reported as non-serious. Patient received on advil at night for treatment of events. The outcome of events was recovered on an unspecified date. No follow-up attempts are possible, No further information available

Patient was given vaccine at 10:45am - Patient reported scratchy throat at 10:48am - at 10:50am we gave 50mg of Diphenhydramine orally, patient condition worsened, she described her throat starting to swell up, and had noticeable difficulty breathing and shortness of breath. We administered Epinephrine at 10:55am and within 5 seconds patient reported improvement. Patient remained stable until EMS arrived about 5-10 minutes later. Patient was advised to be taken to the hospital for monitoring and agreed. She remained stable and reported an "itchy back" upon exit.

chills; injection site pain; headache; muscle pain; fever/tiny fever; impacted lymph nodes/lymph nodes are impacted a little bit; nausea/feeling nauseous; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206) via an unspecified route of administration, administered in Arm Left (left shoulder), at the age of 61-year-old, on 03Mar2021 19:00, as SINGLE DOSE for covid-19 immunisation. The patient medical history was overweight, diagnosed COVID last Apr2020 she had it for 17 days and had every symptoms. The patient tried to give antibodies for many months and she was told she had two different kinds of antibodies which prevented her from doing that. The patient has long hauler symptoms which are nerve pain in her thighs and mouth. The patient's concomitant included an unspecified medication (she takes something but not relevant). The patient did not receive any vaccine within 4 weeks prior. The patient previously received shingles vaccine on 14Feb2020 and tetanus shot on an unspecified date (years ago) both given for immunization and her arm hurt/ pain at the injection site (if she touches it, it hurts). On 03Mar2021 at 7PM, after receiving first dose, she felt blah described as she developed injection site pain which is dissipating but still there, headache, muscle pain, tiny fever, impacted lymph nodes, nausea/ feeling nauseous which she didn't have before. The patient can get up and walk around. On 04Mar2021, the patient had chills in the afternoon. It was just a little fever. The patient took Tylenol and Advil in the afternoon and it helped it go away. The patient took one of each. It was reported that the COVID headache is like none other and she had the headache again. For the COVID headache if you take things it doesn't make it go away. When the patient said she had the headache again she meant she had the same headache that she had in April. The events did not require ER or physician office visit. Outcome of injection site pain was not recovered while it was unknown for the other events. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

The rash began as a faint red macular rash below the knee on the left leg before progressively spreading and involving the contralateral leg, lower abdomen, and bilateral upper extremities. The rash was mildly painful but not pruritic. She was otherwise asymptomatic. On examination, the patient was afebrile and well appearing. There was erythematous to violaceous palpable purpura scattered on the lower abdomen, lower legs extending to the feet, and forearms extending to the palmar hands. The lower extremities had several dusky violaceous vesicles, some with superficial erosions. Punch biopsy confirmed Leukocytoclastic vasculitis. She was treated with topical corticosteroids and rash is still resolving.

feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.

Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.

4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with bleeding sores on tongue and side of mouth. Began to have bruises on arms, feet and legs. Blood in urine and bruises on back. Presented to emergency department on 4/11/21. CT brain revealed a right sided posterior temporal hemorrhage. Patient was emergently treated with platelets, DDAVP, factor VII, Decadron, IVIG. 4/12/21, patient denies headache, changes in vision, double vision, change in sensation, including burning, pinprick, numbness, no focal or motor weakness. No change in bowel or bladder control. No sensory changes. Patient states she is now back to her normal state of health, save for the bruising described.

Within 1 hour severe side effects: body aches, cough (dry like asthma) , fatigue, dizziness, chills, nausea, could not sleep, Swelling, warmth, burning swellinge first dose size of 1/2 orange. No fever. Second not as severe as the first. Body aches, muscle pain, dizziness, chills, nausea, painful injection site not as much swelling,No fever. Blood Sugar spikes: 1/31/2021 280, 2/1/21 2112/27/21 319, 2/28/21 418. 9 days after second vaccine. Purple swelling of both feet. cellulitis rt foot pain worse in lt than rt .PCP to ER (soles, top lower legs black): susp tibial artery occlusion lt . Heparin. Farxiga, Ultram, baby aspirin, procardia, metformin.Possible Reynauds.Still pain discoloration and swelling.

My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.

anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

After the vaccination, I experienced pain and tingling/numbness in upper arm radiating to under the arm. Throughout the day and into the night I had pain, redness, itching and swelling at injection site. The next day (21st) a hard lump developed under the skin where I had the injection. I also had a headache and muscle aches. I didn't take any medication for the pain and discomfort as I was told it was beneficial to let the reactions occur without drug interaction or interference.

The patient had a localized rash near the injection site. The patient was told to monitor the rash and report to the ED if symptoms continue or worsen.

Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization. Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.

Her platelets are 200, which is very low; Bell's palsy; Shot on the top of my shoulder; excruciating pain/shoulder pain/given high on the top of her shoulder. It hurt; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 61-years old via an unspecified route of administration on 19Mar2021 10:10 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included systemic lupus erythematosus from 1985 and ongoing, arthritis and osteoarthritis from an unknown date and unknown if ongoing (She has osteoarthrosis throughout her body and her feet). Family history included stroke (husband died at the age of 59, he was having stroke upon stroke). The patient's concomitant medications were not reported. It was reported that when she received the shot, it was given high on the top of her shoulder and it hurt. She could not move her arm for 3 days. The pain was excruciating. On the 4th day, her arm was sore, but she could move it. She had no fevers, she didn't get sick, but she just couldn't move her arm. The shot was given at at 10:10 am, and by noon she could barely move her arm. Her left side of the mouth doesn't want to work properly. Her Bells Palsy started on 05Apr2021. She was in her car and driving to the store, when all of a sudden her left eye was watering. She got home and she didn't see anything wrong with her eye, except it was watering. She could tell a difference between the left and right side of face when she touched it. Something was wrong with her right side. Her eye was not opening all the way, it's been dropping, and her lip was down. She can't smile, and when she drinks water it's comes out. The patient clarified that it was her left side that is drooping. She went to the emergency room due to Bell's palsy. She could not move her arm within 2 hours of getting the shot. The patient mentioned her whole body aches from the Lupus and arthritis, but the shoulder pain was different after the vaccine. The shot itself hurt, and she thinks the one who administered the vaccine might have hit something. There's not a day that doesn't go by that she is not in pain. Her platelets are 200, which is very low. The patient underwent lab tests and procedures which included activated partial thromboplastin time: unknown result, blood glucose: unknown result, computerised tomogram: unknown result, full blood count: unknown result, glomerular filtration rate: unknown result; all on 06Apr2021, magnetic resonance imaging: showed a darkened area in her brain that looks like its connected with Bells Palsy on an unspecified date, basic metabolic panel: unknown result on 06Apr2021, platelet count: her platelets are 200, which is very low on an unspecified date, prothrombin time: unknown result, troponin i: unknown result (High sensitive ); both on 06Apr2021. The patient did not recover from Bell's palsy, recovered from vaccination site pain on 23Mar2021, from sore arm on 19Mar2021 and the outcome of the remaining event was unknown. Information about Lot/batch number is requested.

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

the site was swollen and red, draining pus; the site was swollen and red, draining pus; the site was swollen and red, draining pus; This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received the first does of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 16Mar2021 13:15 (Batch/Lot Number: EN6204) (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, spinal neuropathy and allergy to latex. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Past drug history included the patient had allergy to acetylsalicylic acid (ASPIRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the site was swollen and red, draining pus and she cleansed the area and it was size of a walnut. The area opened on its own with a moderate amount pus. The patient had no fever. She had been cleansing and keeping the area clean and dry. She kept applying antibiotic and cove. It was red but no drainage. It had not spread. The patient had no other symptoms. The outcome of events, the site was swollen and red, draining pus was recovering. No follow-up attempts are needed. No further information is expected.

Feeling like maybe there is something wrong with her spleen; The pain is in the left side of the back kind of by the lungs; She has been sick; Her mental status was also affected; What scared her was not feeling like she was getting enough oxygen; Nausea; Body pain/flu-like body pain in her muscles over her shoulders; Out of it; Pain in her back where her lungs are; Problems breathing/Her breathing still almost feels labored; Hot and cold sweats; Dizzy; Shaky; Weak; Tired; Headache; Anxious; Fever; Itchy; Arm hurt; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A 61-year-old female patient received first dose BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 09Apr2021 13:00 (Batch/Lot Number: TW0151) as SINGLE DOSE for covid-19 immunization. Medical history included cancer, pneumonia, pain in her lungs, smoker and arthritis. The patient's concomitant medications were not reported. The patient experienced what scared her was not feeling like she was getting enough oxygen on an unspecified date, problems breathing/her breathing still almost feels labored on 11Apr2021, arm hurt on 09Apr2021, pain in her back where her lungs are on 11Apr2021, hot and cold sweats on 10Apr2021, dizzy on 10Apr2021, shaky on 10Apr2021, nausea on 13Apr2021, body pain/flu-like body pain in her muscles over her shoulders on 11Apr2021, out of it on 11Apr2021, weak on 10Apr2021, tired on 10Apr2021, headache on 10Apr2021, anxious on 10Apr2021, fever on 10Apr2021, itchy on 09Apr2021, feeling like maybe there is something wrong with her spleen on an unspecified date, the pain is in the left side of the back kind of by the lungs on an unspecified date, she has been sick on an unspecified date, her mental status was also affected on an unspecified date. Patient had the first dose of the Covid Vaccine on 09Apr2021 and gradually her arm hurt, she had hot sweats, she felt dizzy, was shaky, had nausea, and had body pain. The one thing she is concerned about was she had pain in her back where her lungs are and she was having problems breathing. She has a little bit of that still. She has also been out of it. Her breathing still almost feels labored, and this past weekend she thought she would go to the emergency room. Her main concern is this awful pain in her back while she was having problems breathing and getting enough oxygen. She felt weak, dizzy, and shaky. She got scared. She has been sick, she had cancer a long time ago. What scared her was not feeling like she was getting enough oxygen. The pain is in the left side of the back kind of by the lungs. It goes directly from the front to the back. On Monday it started feeling better. Today it is so much better. She will feel like she is not getting enough oxygen or giving a full breath and then this in her back. She remembers having pneumonia years ago and having pain in her lungs. That's why she knows the pain is in the back of her lungs. She has to say she is a smoker. She slowed down and couldn't smoke this week or during that. She kind of quit, that's her reality now. The pain comes and goes throughout the day but it is not as bad. She didn't have this shortness of breath and other things until a couple days after she got the vaccine. It gradually came up on her. She was not having trouble breathing, it was more slightly labored. It was not profound, just there. Sometimes when she is speaking after a while she gets tired and will have to take a moment and take a deep breath. It is so much better. She called her primary care physician and was anxious, and all he said was she would feel effects for 2 weeks. He wasn't very helpful. Her arm hurt the day that she had the shot. Even today there are little bits of pain but very light. 09Apr2021 through 11Apr2021 was when everything really hit. It was hard to lift up her arm. It was a little pain, it was no big deal. She would have the AC on and blast it when she had the hot and cold sweats. She was using napkins because she was sweating profusely. It felt like she obviously had a reaction to the vaccine. It's normal she guesses. She didn't expect it for the first dose. The 11th, 12th, 13th, and 14th it was really bad. Her whole body was sweating and would get wet. She'd be hot and then cold. She was anxious because she was having problems breathing. She still gets a little bit of hot and cold sweats, but nothing compared to what she went through. As the days go on she is slowly getting better. She was dizzy not just during the day, at night she couldn't sleep because of it. She has gradually gotten better. Yesterday she tried to do some gardening but felt so weak she had to come back inside. When she gets up she feels weak and a little bit of lack of air. She has labored breathing. She was real itchy. The shakiness, dizziness, and anxiety all came on and were horrible. She doesn't know if the nausea was because she couldn't eat and had to take her regular medication. It was very light nausea. She had flu-like body pain in her muscles over her shoulders. Her headache was major too during all of this. The headache is something that comes and goes still. It is a weird kind of headache. She had a fever and got like flu all over body pain. She doesn't know how to explain how she felt out of it. She doesn't know if it was the fact she was so sick. She had a feeling of did she do that. She couldn't make decisions. She would need to take the garbage out and go back to the garbage and think what did she come here for. Her mental status was also affected. The weakness gradually got really bad, and she still hasn't recovered from it. She still feels weak and tired when trying to do things. She was tired the day after she got the vaccine. The first day she thought it was nothing and she was fine. Gradually it got real bad when she was sick. She didn't feel that flu-ish feeling but was weak and tired. She got dizzy and she had the brain fog thing. She was having really bad headaches during the same time. The weakness and tiredness go hand in hand. She takes a mineral for her thoracic spine, but she takes that more for elderly arthritis. She doesn't have any conditions that she thinks played a role. She has been feeling like maybe there is something wrong with her spleen. Took Tylenol for her fever. Mentioned fever would go away and come back. The patient underwent lab tests and procedures which included body temperature: 102, 99 and 100.1 (unit unspecified) all on unspecified dates. Therapeutic measures were taken as a result of fever and itchy. Outcome of the event problems breathing/her breathing still almost feels labored, arm hurt, pain in her back where her lungs are, hot and cold sweats, dizzy, out of it and headache was recovering. Outcome of the event fever was recovered on 13Apr2021, itchy was recovered with sequelae on 14Apr2021, body pain/flu-like body pain in her muscles over her shoulders was recovered on 16Apr2021, nausea was recovered on 16Apr2021, shaky was recovered on 19Apr2021. Outcome of the event weak and tired was not recovered. Outcome of all the other events was unknown.

Very late diagnosing as shingles; Headache at work after vaccine; then got more severe along with leg very sensitive and burning feeling; then got more severe along with leg very sensitive and burning feeling; severe stomach pain; This is a spontaneous report from a contactable other HCP (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 28Jan2021 09:00 (at 61 years old), single dose for covid-19 immunisation. Medical history included concussion, endometriosis, all from an unknown date. Concomitant medications included estradiol; progesterone. No other vaccine in four weeks. On 28Jan2021 09:00, patient experienced Headache at work after vaccine , then got more severe along with leg very sensitive and burning feeling, better then 5 nights very severe stomach pain-Dr appt and ER to get sonogram, CT-Very late diagnosing as shingles. The outcome of the events was not recovered. Treatment of adverse events was CT, Sonogram. No covid prior vaccination. Not covid tested post vaccination. No Known allergies. Information about lot/ batch number has been requested; Sender's Comments: Based on known disease pathophysiology, the event herpes zoster is assessed as not related to suspect vaccine BNT162B2.

1st and 2nd dose- swollen glands; injection site pain in right arm; 2nd dose- shingles/shingles blisters; felt quite ill/not feeling well; second dose- extreme pain in left hand/sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 08Mar2021 (Batch/Lot Number: EN6208) (at the age of 61-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included breast cancer (2-time breast cancer survivor), had lymph nodes removed, and has low thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for low thyroid from an unspecified start date and ongoing; ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, iron, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 nos, vitamin d nos, vitamin e nos, vitamin k nos, xantofyl, zinc (CENTRUM SILVER WOMEN 50+) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication from an unspecified start date and ongoing; famotidine (PEPCIDAC) taken for an unspecified indication from an unspecified start date and ongoing; esomeprazole sodium (NEXIUM) taken for an unspecified indication from an unspecified start date and ongoing. Patient previously took shingles vaccine on an unknown date (reported as number of years ago) for immunization, flu shots on an unknown date for immunization and also previously took the 1st dose of BNT162B2 (Batch/lot number: EN6200) (at the age of 61-years-old) on 15Feb2021, intramuscular administered in the right arm for COVID-19 immunisation, and experienced injection site pain in right arm, sore arm and swollen gland. Patient stated having what was considered typical, like a sore arm and did have some swollen glands with the first and second dose. It was also reported that after 1st and 2nd dose, there was injection site pain in right arm. After second dose she developed shingles, or what was later found out to be shingles, she had extreme pain in her hand. She thought it was injured or something, it was very painful. She got shingles blisters on her hand, and then also got some on her arm, the opposite arm as the injection. Her dermatologist and internist verified it was shingles. Her internist said it may have been triggered by the vaccine. She clarified it started in the palm of her hand and then traveled up her arm on the opposite side of the vaccine, she got the vaccine in the right arm and the shingles in the left arm. She felt quite ill as a result of the shingles. Her dermatologist put on Valtrex, three times a day. It helped with the spread; it stopped spreading. Her dermatologist was not associating it with the vaccine, and she was not sure she was either. After not feeling well for several days she told internist and he was confident that the vaccine was what caused the shingles. She doesn't remember for sure the event extreme pain in left hand, but it was within a few days after the 2nd dose. The swollen glands started within 24 hours, as well as, the sore arm. It wasn't anything she didn't expect. Like with the flu shot maybe a little worse, but it wasn't severe. Her sore arm was not ongoing. It recovered completely by the next day. Swollen glands came back when the shingles first happened, but they initially began within 24 to 48 hours, for both doses. After the second dose she took two extra strength Tylenol again on the first night again; she just took it once after the 2nd dose. Pain in the hand was 98 to 95 percent better. Her doctor did whole blood work up (unknown results) just to see her white count (unknown results) to rule out something else. The blisters were too small for the dermatologist to scrape and get a biopsy. She did not get the most current 2 dose vaccine for shingles, she only got one dose and that was a number of years ago, she was going to get it but then COVID happened. The outcome of event herpes zoster and pain in extremity was resolving while for other events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Cellulitis: below left elbow; Soft tissue swelling; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient (62 years old at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscular in left upper arm on 21Dec2020 13:00 at a single dose for COVID-19 immunization administered in the hospital. Medical history included ongoing hypertension and cervical cancer from 2015 and ongoing. The patient has been taking unspecified concomitant medication/s. The patient previously took amoxicillin and had allergies and nausea. On 24Dec2020 16:00, patient had cellulitis below left elbow and soft tissue swelling. On 25Dec2020, patient went to ER and X-ray was taken and patient was prescribed Keflex 500mg 3x day. Prior to vaccination, the patient was not diagnosed with COVID-19: Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the information currently provided, the vaccination with BNT162B2 might play a contributory role in triggering the onset of cellulitis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Had gotten a headache within 1/2 hour of getting the injection. Within 2 hours after receiving the injection my arms started to itch and upper back areas. Within 4 hours I noticed rash like redness with tiny little spots/bumps all up and down both arms and the itching was getting worse with both arms and upper back areas. This went away by Friday evening. I had the headache until the following Monday evening.

Red rash on neck both sides below hyoid to scapula 6 inches from left to right and 3 inches top to bottom. Hot to touch, very red.

starting developing hives on back of my neck and head 6 days after the covid vaccine was administered. The hives progressed to my ears, arms, abdomen, groin, and upper thighs. I started taking Benadryl the first evening the hives started and continued benadryl for 2 more days. The benadryl did not stop the progression or help much with the intense itching. Had a telehealth visit via the telephone with Dr on Monday Jan 4. He ordered Atarax prn. I also started taking Pepcid and Zyrtec. Today I still have hives that are developing but at a much slower pace. The itching is much improved. DO I TAKE THE 2ND VACCINE?

Feeling unwell; Headache; Tiredness; Muscle pain; Chills; Nausea; Injection site pain; had been asleep most of the whole day; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiration date: Arp2021), via an unspecified route of administration on 30Dec2020 at single dose at right arm for Covid virus. Medical history included blood thinner treatment. Concomitant medication included ongoing apixaban (ELIQUIS) for blood thinner treatment. The patient previously took coumadin, warfarin. Patient received the Covid-19 vaccine yesterday. She had been asleep most of the whole day (Dec2020). She had injection site pain, headache, tiredness, muscle pain and chills. She thought she was going to work but that didn't work. She was currently taking Eliquis. She had been on coumadin and warfarin before. She looked at the different medications that needed to be reported. She would also call her physician and make her aware. The start date for "Injection site pain" was 30Dec2020. The start dates for headache, tiredness, muscle pain and chills all were 31Dec2020. The patient also experienced nausea, feeling unwell on 31Dec2020. Investigation assessment was no. The outcome of the event "Injection site pain" was not recovered. The outcome of the other events was unknown.

Swelling, and warmth at injection site, right arm; Swelling, and warmth at injection site, right arm; swollen and tender right axillary node under right arm; swollen and tender right axillary node under right arm; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140), intramuscular on 22Dec2020 10:30 at first single dose at arm right for covid-19 immunisation . Medical history included breast cancer, allergy to penicillin, levaquin, neosporin, cocoa butter. Concomitant medication included vitamin c [ascorbic acid]. The patient experienced swelling, and warmth at injection site, right arm, swollen and tender right axillary node under right arm on 28Dec2020 16:00. No treatment for events. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.

after initial, expected, deltoid aching pain which lasted for a few days, very mild achiness has persisted. at approximately 1.5 weeks (17d), I noticed actual weakness when I attempted to lift weights (5#) above my shoulders. isolated to the left arm, which was the injection site. Exercising now, daily, with very slow response and increased aching. despite history of intermittent radiculopathy, there had been no weakness prior to the vaccine. Is this a reported vaccine AE?

swelling and joint pain in the little finger on left arm; swelling and joint pain in the little finger on left arm; She got a bruise at the injection site; It bled a little bit when she put it in; This is a spontaneous report from a contactable nurse (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231), via an unspecified route of administration on the left arm, on 28Dec2020 at 14:15 at a single dose for Covid-19 immunization. Medical history included environmental allergies, she has allergies and can have an asthmatic attack from cat dander and perfume, blood pressure (abnormal) and sleep (disorder). Concomitant medications included ongoing lisinopril for blood pressure, colecalciferol (VITAMIN D), acetylsalicylic acid (BABY ASPIRIN), paracetamol (TYLENOL). The patient previously took novocaine but was allergic. She got all this information when she got the vaccine on Monday at (place name) in (state name). It tells all the side effects from the first injection. She wanted to report that it is the same arm that she got the vaccine in. She has swelling and joint pain in the little finger on left arm. It says you can have joint pain, but nothing about swelling. She thought she better report it. This was her first shot. She is supposed to get the second one on 18Jan2021. She wanted to make sure she can take it. She received the vaccine on 28Dec2020. She laid around that day. Today is the first day she doesn't have arm pain and swelling at the injection site. It was the first time she has had arm pain. She has never had that with flu shot. The arm pain started within the 15 minutes she was observed. It hurt like hell until that day. She got a bruise at the injection site. It bled a little bit when she put it in. Swelling and joint pain in the little finger on left arm: she doesn't know if it was later that day. She can't remember. She really noticed it yesterday. She has never had joint pain or swelling. She doesn't have any problems with arthritis. Now her little finger is bigger than the rest of her fingers. It hurts because of the swelling. She doesn't want to take anything. It might be fluid. She has a high pain tolerance. She keeps bending it thinking it will get better. It isn't as bad, but its still swelled up. At first she thought it was better, but it is still pretty swollen. To her this is a reaction. She was thinking if she took paracetamol before, it wouldn't hurt as bad, but she can't remember if she took it that morning. She takes 500mg before bed for the heck of it at night. It helps her sleep better. She has allergies and can have an asthmatic attack from cat dander and perfume. They think she was allergic to the preservative in the flu shot, but she has never had any trouble with the flu shot since. She has environmental allergies. They thought she was allergic to Novocaine once at the dentist office. Who knows, it only happened once. She's been to the dentist many times and who knows what they injected and why she reacted that way. She felt like she was going to pass out. They don't give it to her anymore. She doesn't know what was in it. She is worried since this vaccine is emergency authorization. She doesn't want to get the next one and have a worse reaction. She is not sure if she should be worried. The events of swelling and joint pain in the little finger on left arm were assessed as medically significant. Outcome of the event of 'swelling of fingers' was not recovered, the other events were unknown.; Sender's Comments: There is a reasonable possibility that the event joint pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the event swelling with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Fine pin point rash and itching noted 45 minutes after shot given. Rash noted to neck,spine,hips,upper back,upper chest and bend of both arms.Benadryl 25 mg OTC 1/6/21 and 1/7/21.Itching. Itching decreasing 1/8/21. Having copious side effects also of injection site pain,tiredness,headache,joint and muscle pain,nausea,lymphadenopathy and feeling unwell.1/6/21,1/7/21 but feeing better when tylenol 500mg ing system to relieve aches and pains

Itching; This is a spontaneous report from a contactable consumer reporting for herself. A 62-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in the left upper arm on 02Jan2021 13:00 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced itching on 02Jan2021 with outcome of not recovered. The patient got the COVID vaccine on 02Jan2021 around 1 o'clock. That evening (5-6 hours after getting) the vaccine she started itching and has been itching since then. The itching is on her body, back, and stomach. She has been itching since, it comes and goes. Itching worsened. It also worsens in the evening, night, and morning. As treatment the patient took a baby loratadine (CLARITIN).

My body had started itching and I didn't know why. I had not eaten anything new or changed any shampoo or soap. Finally on Thursday night I realized maybe it is the shot that is giving me all the itching. My whole body was flushed I kept scratching my arms and legs, especially around my ankle, knee, under arm and goin area. I took an allergy pill and called Kaiser and spoke with an advice nurse. she mentioned that taking an allergy pill will relief some of the itching. I fell asleep around after midnight normally I go to bed around 9:30. I also called pfizer and explained and the person took all my information and symptoms.

Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.

c/o mild itching. 132/78, 78, 18, 99% O2 sat. Narrative: After vaccine c/o mild itching. Cetirizine given PO. Observed 30 min. @ 1340: 132-78, 78, 18m 99% O2 sat. Feeling better. D/C'd stable

About 13 hours after injection I started having extreme chills and shaking. Took 2 Ibuprofen and the chills subsided during the night and then had mild/moderate body aches for about another 12 hours. About 48 hours after the injection the top half of my arm is currently slightly swollen, red and hot to the touch.

Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p

Arm pain @ injection site, able to sleep on right side; relieved with Ibuprofen. Headache, mild, next afternoon, relieved with Ibuprofen.

ON 12/31/20 AT 1PM, DEVELOPED SORENESS AT INJECTION SIGHT, GREATER THAN NOTICED WITH OTHER VACCINATIONS. LASTED 48-72 HOURS. ALSO HAD HEADACHE, WHICH WAS PRESUMED TO BE SINUS HEADACHE, BUT DID NOT RESPOND TO SINUS MEDICATION. HEADACHE CONTINUED THRU 1/1/21 WITH NAUSEA ALSO NOTED. SYMPTOMS SUBSIDED BY 1/2/21

On 1/6/21, I received the initial COVID vaccination. Later that evening, I started to experience pain, swelling and redness at the injection site (right arm). I also had a severe headache with nausea. I was directed to get a COVID test, at the hospital on 1/7/21. I continued to experience these side effects of the vaccine for the next 2 days.

Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset of runny nose and itching of eyes.

shaking; weak; cough; shortness of breath; very ill/ sick; horrible chills; I had a 103 degree fever for 4 days, horrible chills that were just debilitating; ached everywhere/ severe aches; site soreness; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) via an unspecified route of administration at left upper arm on 18Dec2020 at single dose for COVID-19 immunization. Medical history included auto immune problems, diabetes, thyroid condition, all ongoing since age 28; pemphigusvulgarism since Sep2020 and ongoing. No concomitant medications. Patient is a frontline worker. She received the vaccine on 18Dec2020 at (Name) where she works. 9 days later she got very ill. she didn't know if it's unrelated. She wanted to know if there is anything she need to be watching out for in order to get her second vaccine on Friday. She was so sick and she did have some autoimmune problems. She was really healthy. On 26Dec2020, she had a 103 degree fever for 4 days, horrible chills that were just debilitating. She was just shaking. She ached everywhere, she had severe aches since 26Dec2020. She got tested for Covid and it was negative on 28Dec2020, she had no cough and no vomit. She stayed in bed and drank lots of fluids and toughed it out. By New Year's Day (reported as 30Dec2020) her fever broke but she was so weak and didn't work. She was back at work now. Also, she experienced site soreness from the injection since 19Dec2020. She did have a cough or any shortness of breath. She felt awful. She had recovered. She was just a little nervous because everything she read said the reaction was more severe with second injection. She planned on getting the second shot. She would have a repeat Covid test on 07Jan2020. Reporter seriousness for fever 103: Medically significant. Reporter seriousness for severe aches: Medically significant. Reporter considered the causality of the event site soreness was related with bnt162b2, of the events fever 103 and severe aches was unknown. The outcome of the event fever was recovered on 30Dec2020, of event ache was recovered on 31Dec2020, of event chills was recovering, of event vaccination site pain was recovered on an unspecified date in Dec2020, of events cough and shortness of breath was recovered on an unspecified date.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fever, pain and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

2nd dose- Headache, bodyaches pain at injection site and bruising; symptoms lasted for 24hrs then resolved. Pain and tenderness persist at injection site. 1st dose - no reported adverse events

A chest x-ray showed some inflammation on the lungs; Slight pain in her arms after taking the vaccine; Bad headache; She started to develop a cough after the injection that did not improve and had worsened by the end of the second week; This is a spontaneous report from a contactable Nurse (reporting for herself). A 62-year-old female patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, batch/lot no. and expiry date: unknown), via an unspecified route of administration on 18Dec2020 at a single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. As reported, patient asked, "should I get the second injection of the COVID-19 vaccine since I have this cough that will not go away?." This female nurse, who was also the patient, reported receiving her first injection of the PFIZER COVID-19 VACCINE on 18Dec2020. She started to develop a cough after the injection that did not improve and had worsened by the end of the second week. Treatment has included cetirizine (ZYRTEC), dextromethorphan (ROBITUSSIN),Guaifenesin (MUCINEX) and albuterol inhaler. A chest x-ray showed some inflammation on the lungs and she was given a steroid inhaler, which has helped. She has received two COVID-19 tests at different time intervals, and both were negative. She was scheduled to receive the second COVID-19 vaccination on Friday but was uncertain if she should receive it given her cough was not improving. She had a bad cough, and other symptoms just before her injection (pending clarification). But her general practitioner (GP) put her in a steroid inhaler. She talked to her GP but can't give her complete advice as to whether she can still take the 2nd dose or not due to her situation. She said she had very slight pain in her arms after taking the vaccine, and felt a really bad headache on 18Dec2020. She would like to know if she still needs to continue the 2nd dose of vaccine or not since she still has a cough. Patient asked if there was any guidance on getting a second dose and what if test was a false positive and she really did have COVID-19?. Outcome of the event "She started to develop a cough after the injection that did not improve and had worsened by the end of the second week" was not recovered while "A chest x-ray showed some inflammation on the lungs", Slight pain in her arms and Bad headache were unknown. Information on the Batch/Lot number has been requested.

During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.

Immediate numbness/tingling in left arm and left hand and both feet. Left arm/hand symptoms lasted ~15 minutes. Symptoms in both feet lasted 5-6 hours and continue intermittently.

1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills

C/O ITCHINESS AROUND MOUTH. OBSERVED X15 MINS. STATES FEEL BETTER AND REFUSED ER EVAL. TOOK BENADRYL AND WENT HOME WITH RELIEF. VITALS STABLE. O2 SAT 98%

Patient received the vaccine (dose 2) on Thursday, woke up early Saturday morning with hives all over body - no history of reaction to anything. Did not take anything. Went back to sleep. Reaction resolved within 4 hours. No other identifiable changes in diet or detergents.

Almost immediately after the injection, I noticed a metallic taste. It was mild enough that it did not interfere with the taste of foods or drinks. It was noticeable whenever I had not had anything by mouth for a while. This lasted for 2 to 3, maybe 4, days. Soreness at the injection site, and stiffness of the arm, began the evening after the injection. Warming applications and moving the arm relieved these symptoms. They were gone the next day.

2nd dose next day had nausea in am since subsided. chills muscle aches and swelling soreness at arm site present @ this time.

Swelling at the injection site. Looked like a bubble and swelling was slowly spreading. Pt did not report dizziness or trouble breathing. Blood pressure machine was not accurate so bp not reported.

left arm pain at injection site, barely able to lift arm above shoulder without pain for first 2 days. 2 weeks later, still painful at injection site and general left deltoid area. no pain to touch, just with movements. pain with certain range of motion

12/21/20 - SYMPTOMS STARTED ONE HOUR AFTER RECEIVING THE VACCINE. DIZZINESS, HEADACHES FOR 24 HRS. PAIN ON INJECTION SITE. TOOK TYLENOL.

EVENING OF 12/28/20, DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, FATIGUE, AND INJECTION SITE PAIN. RESOLVED BY 12/30/20.

Had second injection 10 am on 1/16/21 . Woke up at 1:30 am during night on 1/17 with rigors, took tylenol, temp in am 99.6. Had headache next day, Ok with tylenol. Woke up in am of 1/18/21, itchy all over. Looked in mirror and had hives over right side of torso in back, and on chest and abdominal area in front. Very itchy. No shortness of breath. O2 sat 96%. Took 10 mg of Atarax I had at home for allergy itching. Called our Occupational Health office, instructed to call back if worsens or unresolves in next 24 hours.

I had my first vaccination on 1/11/21 at HD. The reaction was typical- significantly sore red inflammed arm over deltoid muscle that resolved after 3 days. Second dose given 21 days later- some swelling and soreness, low grade fever. Then 3 days later, I awoke, turned in bed and experienced an intense shearing pain in my neck and arm. The pain was the worst ever felt, and was not improved with NSAIDS, Acetaminophen, Hydrocodone, or Tramadol. I went to an urgent care center on 1/16 where a tentative diagnosis of sprained neck was made. The sypmptoms continue with slight improvement with steroids, and a muscle relaxant. I am concerned because I understand that covid itself can impact the nervous system considerably. I am awaiting improvement in symptoms and if none seen then I will see my primary care MD

Once i received the 2nd dose- My arm swollen for 3 days - continue to be red as thought rash going over the top half of arm around the injected area. chills , body aches, fever. stayed in bed the next 3 days. 4 day sweating, and low grade fever , fatigue very weak.

30 minutes after being vaccinated with Pfizer vaccine (second dose) in her right arm, employee developed itching and red splotching (not elevated) on her left arm. She had no difficulty breathing, no swelling and said she "felt fine" except for the itching. She took Allegra about 1:30 pm. We recommended she call her husband to come and take her home and to go to ER if symptoms progressed. She declined. At about 3:00 pm redness was improving on upper arm but had spread down to the palm of her hand. Again she stated she felt fine. Patient drove home on her own about 4 pm but agreed to text Nursing Supervisor when she got home. She reported at about 7 pm that she was greatly improved. Follow up today (1/21) itching/redness is gone but does have body aches and headache. Her only known past allergy is to Sulfa drugs. No issues with first dose. Let employee know that if there is ever a reason for another covid vaccine that she would have to have it done in the care of a doctor's office.

Bruise in arm; I lost some weight; This is a spontaneous report from a contactable Consumer. This consumer reported for herself that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on unknown date at a single dose for covid-19 immunisation. Medical history included "I went to the doctor because I wasn't feeling well just little congestion inside my lungs." Concomitant medications included "Yes, Antibiotics, I was worried I didn't think about it since I think about it yesterday, wow is this going to effect the vaccine (further not clarified)." Consumer stated, "I have a question I received the First shot (clarified as Covid 19 vaccine) here 20th of this month I get my second but 7th of this month I didn't even think about it I went to the doctors even though I was negative and they put me on antibiotics is that going to interfere with the vaccine. Consumer stated, "I guess no, I had no side effects, I got a bruise in my arm and that was all." Consumer stated, "120 pounds, I lost some weight." Consumer stated, "I just had my blood count checked that's all." The outcome of the events was unknown. Information on the lot/batch number has been requested.

Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy". She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time. Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time. Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension

tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.

Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was noted to have some throat clearing but denied any concerning symptoms. At 9:40 she began experiencing fluttering in her chest and at 9:41 she was noted to have some chest tightness and wheezing. She was given Benadryl 50 mg oral at 9:42 but then symptoms began to progress and she started to have angioedema of her upper lip and her hands/arms started itching and she was noted to have some early hives. Epipen 0.3 mg was given at 9:45. She continued to have some swelling of her upper lip and chest tightness and soulmedrol 125 mg IM was given at 9:49 and then she was placed on O2 via NC at 2 L. At 9:50 she stated that her throat swelling was starting to improve and her chest tightness and wheezing was getting better. EMS arrived at about 9:51 and report was given and care turned over to them. They left the clinic at 10:00 without further incident.

Patient c/o shortness of breath and "throat closing up"after receiving Covid vaccine at 10:00am.. O2 started at 4l/min via n/c at 10:10am. , BP taken and advised to administer her Epi pen that she had with her due to allergy to Gelatin, administered Left thigh by patient.at 10:15am. 911 called at 10:20am. BP 152/93 HR 80 at 10:25am, 154/105 HR 75 at 10:27am, 148/92 HR 75 at 10:30 when departed to Medical Center. 02 sat remained at 99%. Skin warm and dry and remained alert through out process.

Systemic: Rash (other than injection site), Systemic: Chills, Systemic: Generalized Body Aches , Systemic: Headache.

Client approached a Public Health Nurse after 30 minutes of waiting and stated her hands felt itchy, prickly, and were reddened. Denied SOB and denied chest pain. Benadryl was offered and taken, client felt better after that and was released, offered a ride home, but left with a friend.

Patient self-reported to the hospital's electronic ADR reporting system. In her own word, "After 2nd dose of Pfizer COVID-19 Vaccine 1/15/21, the injection site became swollen , itchy, and painful. The following day, under my armpit was swollen and painful. This lasted for 5 days".

The next day after the vaccine my arm was red and really painful. Each day the redness got larger and by friday it was near my elbow so I went to an Urgent Care. I was given a prescription for an antibiotic because they states infection had set in it and I also took tylenol and antihistimines to help with the pain.

Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour 12 and ending at hour 23 post shot and fatigue the entire next day. 48 hours after vaccine all symptoms are gone.

Within a minute -face,ears,neck turned bright red. Paramedics took EKG and BP was 211/110. That morning ( I check it regularly due to salt sensitivity) it was 123/69 (Normally 120-140/ 60-76.

hives on back of my head neck ,ears that progressed that day to bilateral arms, abdomen groin/hives also on my thighs; This is a spontaneous report from contactable nurse reporting for herself (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), via an unspecified route of administration on 26Dec2020 20:15 (reported as 08:15 PM) at single dose on the left arm for COVID-19 immunization. Patient is not pregnant. Medical history was reported as none. No known allergies. There were no concomitant medications (reported as "I take no meds"). No other vaccine in four weeks. No COVID prior vaccination. On 01Jan2021 10:15 PM, 6 days after 1st vaccine, patient started having hives on back of her head, neck, ears that progressed that day to bilateral arms, abdomen groin. The next day hives were also on her thighs. The patient had hives for a week. Treatment for the event was reported as "Zyrtec Pepcid atarax prednisone". Event resulted in doctor or other healthcare professional office/clinic visit. Outcome of the event was recovered in Jan2021. Patient was not tested for COVID post vaccination.

migraines; arm is sore where the injection; she could hear like blood going through her, and if she moved it got faster and faster; Chills; muscle aches; not feeling well; Headache; fever; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 21Dec2020 by injection once to right arm (Lot Number: EJ1685) at SINGLE DOSE, via an unspecified route of administration on 11Jan2021 (Lot Number: EL3302) at SINGLE DOSE for covid-19 immunization (reported as healthcare worker, medical receptionist). Medical history included Other Conditions No. There were no concomitant medications. The patient experienced fever on 11Jan2021, headache on 12Jan2021, chills on 12Jan2021 23:30 , muscle aches on 12Jan2021 06:00, not feeling well on 12Jan2021 , migraines and arm is sore where the injection on an unspecified date. The caller had her second vaccine (later clarified as COVID vaccine) on 11Jan2021, and had the same symptoms as on the first one. They were not as bad, and she thought the first one was pretty bad. She previously reported her symptoms with the first vaccine. Symptoms with the second were fever, headache, chills, of course, and muscle aches, her arm weighs a ton, and not feeling well. Fever was noted when she was sleeping, it is now 99.6, but it was was 103. Headache was noted in the early morning, it was not a normal headache, it was the worst thing, and she is prone to migraines, but this was not even like that, she could hear like blood going through her, and if she moved it got faster and faster, one time, she stood still and it was like ahhh! Chills started about 11:30 last night, they went away this morning, about 11AM. Muscle aches started at 6AM yesterday, and are finally gone, as of probably about 9AM, they are fine now, just her arm is sore where the injection was. Not feeling well started yesterday and is getting better. First dose was 21Dec2020, she previously provided lot EJ1685, confirms both were Pfizer vaccines. The outcome of the event fever, not feeling well was recovering, headache recovered on 13Jan2021, chills recovered on 13Jan2021 11:00, muscle aches recovered on 13Jan2021 09:00. No follow-up attempts possible. No further information expected.

some mild pain at the injection site; This is a spontaneous report from contactable nurses (one is patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some mild pain at the injection site on 15Jan2021 shortly after injection. The outcome of event was unknown. Information on the Lot/Batch number has been requested.

Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl

I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.

Pain swelling redness at injection site. Dizziness, Body Aches. headache stomach distress, tiredness

The vaccine was injected too high in left arm. I know this because I am a retired pharmacist and when I removed the bandage noticed injection was near the shoulder and not in the mid deltoid area. The left arm/shoulder began to feel sore in the evening and was very sore the next day. Was unable to lift arm or move without pain. Over the next several days the severe pain decreased, but I continue to have pain in the arm, especially the bicep area. Range of motion is limited. Severe pain when trying to lift my arm from resting position while in bed. Severe pain when rotating arm inward. Pain occurs with certain movements.

Caller states she received her 2nd dose of covid vaccine on Friday afternoon. Saturday morning she started with Left arm redness, swelling and soreness. Today the redness and swelling measures about 4x6. She also reports noticing a swollen lymph node to her left arm today. She denies fever. She has been taking tylenol and motrin, but has not tried compresses to injection site. She will call her PCP to schedule an appointment for tomorrow.

Nausea, fever , aches and pains all over , flu like symptoms , Rash from chin to chest , itchy . still have itchy neck chin to chest.

Second vaccine given on 1/28/21. Got sick later that evening with pain & soreness at the injection site. Along with a severe headache, nausea, and chills. The symptoms lingered over the next couple of days. Contacted Employee Heath and manger the following day. Stayed out of work on 1/29/21.

pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.

rash in the top of right hand/rash on the left hand; looks like dryness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN9899), via an unspecified route of administration on 15Jan2021 at 13:30 on the left arm at a single dose for COVID-19 immunization. Medical history included partial seizures complex, asthma, beginning of heart disease and high cholesterol all from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had no prior vaccination within four weeks. The patient stated she has a rash on the top of her hand right hand and rash on the left hand; it is real dry, it looks like dryness, on 18Jan2021. The patient stated that she doesn't know if it is allergic reaction. She needs help to figure it out. She is asking if she needs to see her doctor. The patient stated that otherwise, the vaccine was healing her and helping her. She stated that she knows you can have a rash all over your body and she wants to know if that is going to happen. She clarified she noticed the rash on the top of her right hand - not the palm. She isn't sure if it came from taking out the trash or cleaning stuff or some other reason. She stated that it is now trying to get on the other left hand too. She said you can't really tell it on her left hand but she noticed it on the night of 18Jan2021. She is unsure if when she washes her hands it is getting from the right hand onto the left hand. She just needs to know if it is from the vaccine or if she needs to stop taking out the trash or maybe wearing gloves. She is scheduled to receive the next dose on 5Feb2021. She lives in a senior facility building. One of the staff members got COVID so they had to get the vaccine. The adverse event did not require a visit to the physician or emergency department (ER). The outcome of the events was not recovered.

Patient had some flushing, sweating and headache. Patient also had generalized itching over entire body. no rash noted.

Pt came in for 2nd dose of Pfizer vaccine, pt reported itchiness on right arm. Provider informed, assessed pt's arm and torso and determined that the patient had hives that begin on her neck, and spread throughout her torso. Provider recommended she follow up with urgent care to manage the hives, and reschedule second dose of Pfizer vaccine to a later date.

headache; Itchy; prickly skin all over body; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on the right arm on 10Jan2021 at 09:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EK5730 on 20Dec2020 at 09:00 AM on the right arm for COVID-19 immunization, and Benadryl. The patient took Benadryl before the second dose and throughout the day, and it somewhat helped with the constant skin irritation. On 10Jan2021, the patient experienced headache, itchy and prickly skin all over her body. No admission to hospital involved and no treatment was received. The events resolved on an unspecified date in 2021.

Got injection Friday at 12 noon, Saturday morning woke up with fever 101.2, diarrhea x 12 hours, headache x 3 days (frontal) on Sunday developed a baseball size red, hard and warm to touch raised area around injection site. This lasted for 3 days

My blood pressure shoots up really high; My upper body got red like tomato; I was really like confused for several hours; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration at left shoulder on an unspecified date at single dose for COVID-19 immunization. The patient medical history included food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient reported that: "my reaction was my blood pressure shoots up really high and my upper body got red like tomato and I was really like confused and 'spacing' for several hours". The patient did not receive any treatment. The patient outcome of the events was unknown.

lower left side back pain; received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward; rash; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: not reported), via an unspecified route of administration, on 15Jan2021 12:53PM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. It was not administered at a military facility. The patient did not receive other vaccines within 4 weeks prior to receiving the Pfizer vaccine. Medical history included allergies/allergy from childhood 4 years old, back problem from 2001, back surgery in 2015, vaginal dryness, high cholesterol, depression, acid reflux, surgery in 2015, physical therapy, and allergy to mold, dogs, roaches. She has multiple allergies from childhood including allergy to mold, dogs, and roaches. She also mentioned she has had back problems since her first surgery in 2015. All of these predate treatment with Pfizer COVID 19 vaccine and Lipitor. She got to where she couldn't stand up straight, but she went to physical therapy. She had surgery in 2015. She had a problem in 2018 and they gave her shots and that helped. Family history was none. Concomitant medications included estradiol (ESTRING) (for three years) for vaginal dryness, fish oil (taking for three to four years) for high cholesterol, paroxetine hydrochloride (PAXIL) (taking for 20 years) for depression, cyamopsis tetragonoloba gum (BENEFIBER FIBER SUPPLEMENT) (using for a year), vitamin d3 (VITAMIN D3) (using for five years; she used to be on calcium but it can cause heart problems so her doctor told to take Vitamin D), dexlansoprazole (DEXILANT) (taking for five years) for acid reflux, (ALLEGRA) (taking for 5 years ) for allergy, (QNASL) (using for 3 years), allergy shots (used forever) for allergy and stool softener (taking for 5 years) to "keep things moving"; all were from unspecified dates and ongoing. The patient previously took atorvastatin (LIPITOR) for high cholesterol from 2017 to 2017 and experienced back pain from 2017 to 2017 (recovered). She also previously took calcium. The patient experienced "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" on 15Jan2021, lower left side back pain on 20Jan2021, and rash on an unspecified date in Jan2021. The patient called to report a problem with her lower back after receiving the 1st dose of the vaccine. "I've had surgery and a couple of shots, the CAT scan kind. I have been fine for a while, just had a sore arm and yesterday I noticed a problem with my lower back and thought it may have been because I painted, but it is still bothering me. I remembered when I went on Lipitor I started having problems with my back about 3 weeks in, same deal. The doctor took me off and I went back on a month later and I started having problems again. Because I don't know if it was the vaccine, I am wondering if I should get the second dose." She clarified she received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm. She noticed a sore arm right afterward which lasted at least 48 hours. Then on 20Jan2021, she noticed lower left side back pain. Mentions she thinks it is at the L4 or L5 and this is the same place she had a shot there in 2018 for back pain and previously had surgery on that location in 2015. With regard to Lipitor, she is unsure of the exact year, but states it was probably back in 2017. After taking Lipitor she noticed her back pain coming back. Her doctor took her off of Lipitor for a month and it got better. Then he put her back on Lipitor and she had the same back pain problem. She stated that she is unsure if she will take the second dose and asked with regard to her back pain should she take the second dose. Outcome of "received the first dose of the Pfizer COVID 19 vaccine on 15Jan2021 at 12:53PM in the left arm/ she noticed a sore arm right afterward" was recovered on 18Jan2021, outcome of lower left side back pain was not recovered, while outcome of rash was unknown.

Wheal developed immediately upon injection. Bleeding from both site and internally as well. Pressure was held to stop the bleeding. Ice applied to site to help with the swelling Area marked for size determination. Checked arm every 15 minutes during the evening. As of today, still have wheals in two spots and hematoma under the skin as well as tenderness.

Patient developed headache within 24 hours of the vaccination. The headache has persisted. She then developed a mild erythema, mild edema, and pruritus of the palms of both hands 3 days after the vaccination. Also has pruritus of both feet but no erythema. No vesicles, ulcerations, or papules have developed.

slight itchy, tingly, red rash on R foot (plantar surface) and ankle. No blisters. Also some tenderness in lower calf but no rash there. No treatment d/t it being mild reaction

Pain at injection site; mild headache, body aches, nausea, (flu like symptoms). 400mg ibuprofen twice 6 hours apart. Symptoms last 24 hours

After receiving 1st vaccine dose (01/17/2021)- developed rash of the arms "covid arm" After receiving 2nd vaccine dose on 2/7/2021- rash on both arms intensified in color

Six days after the shot I had a severe rash/hives all over my body; Six days after the shot I had a severe rash/hives all over my body; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1284), via an unspecified route of administration on 14Jan2021 03:15 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included Colitis, Arthritis, Allergies to Penicillin, Allergies to Mugwort. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included celecoxib (CELEBREX). The patient experienced ''six days after the shot i had a severe rash/hives all over my body'' (non-serious) on 20Jan2021 07:00. AEs resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. Therapeutic measures were taken as a result of events (treatment: benedryl, zyrtec, Pepcid). The outcome of events was not recovered.

Injection site soreness and dark red circle for 3 weeks Severe chills 4 days Dizziness Headache Nausea

Severe body aches, headache, pain under arms, pain at injection site and could not lift arm for 26 hours

pain at site of injection at 24 hours post injection. Nausea, diarrhea, headache 24 through 48 hours post injection.

I developed a rash that is very itchy. along the hairline of my entire face and on my shoulders and upper chest (not on my breasts)

A lot of pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3247) via an unspecified route of administration on the left arm on 04Feb2021 09:15 at a single dose for COVID-19 immunization. Medical history included high blood pressure and coronary artery (disease). Concomitant medication included valsartan, rosuvastatin calcium (ROSUVASTIN) and acetylsalicylic acid (BABY ASPIRIN). On 04Feb2021 14:30 the patient experienced a lot of pain at the injection site. No treatment was received for the event. Event was reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Outcome of the event was recovering.

The site got worse through Thursday and was red, hot; Weakness; woke up with 100.5 degrees temperature; Difficulty remembering things; Vomiting; Headache 10/10; developed a red area below injection site/The site got worse through Thursday and was red, hot; This is a spontaneous report from a contactable nurse. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), intramuscular in right deltoid on 24Jan2021 at a single dose for prevention (COVID-19 immunization). Medical history included Low immunoglobulin/compromised immune status/Low immunoglobulin diagnosed 8 years ago, hereditary angioedema from 2010, asthma diagnosed in her 20's, Allergic to Thermarisol, diagnosed allergies, respiratory illness, and endocrine abnormalities (including diabetes) and obesity. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (LOT number: EJ1686) in right deltoid on 03Jan2021 for covid-19 immunization, and flu shot on Sep2020 without adverse event. She got second injection on 24Jan2021. On 25Jan2021, she woke up with 100.5 degrees temperature and could not stop vomiting. She had to go to the ER. They gave her Zofran, IV and also Toradol because she had a number 10 headache. She continued with low grade temperature throughout week from 99.5-100.5 degrees Fahrenheit, and by Tuesday morning, she developed a red area below injection site. By Thursday, there was a red area growth to 13 cm x 15.5 cm on the injection site. She could not remember her email address and said her brain was not thinking. This started after the vaccine that she began having difficulty remember things. She never had a headache that bad. It improved but she has a lingering headache still. She continued to have a temperature from Monday to Saturday. Currently, she does not have an elevated temperature. Difficulty remembering things was reported as just irritating, but significant. The site got worse through Thursday and was red, hot and ended up measuring 13 cm x 15.5 cm. Regarding weakness, she could walk but medics had to help support from her seat to the ambulance. The outcome of the events red and hot injection site was not recovered; the outcome of the events vomiting, headache, weakness was recovering. The outcome of difficulty remembering things was unknown. The outcome of high temperature was recovered on an unknown date. The events was assessed as medically significant.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

Fever, headache, dizziness, muscle and join pain/aches - at time severe, hives, nauseous/stomach ache similar to indigestion, loss of appetite, injection site pain, fatigue

Took 2 benedryl prior to vaccine. Vaccine rec'd at 4:30 pm woke up at 2 am with hives and severe itching on arms, throat and upper torso along with scratchy throat. Hives reappeared for two days afterwards. Should I get the second dose?

Red elevated welt about 4 inches in diameter, like a bee sting. Remained elevated for about 3-4 days and red for 14 days. On day 10 became very itchy.

01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.

Soreness at injection site and fatigue within several hours; headache next morning with slight dizziness

Pain in left back/rib cage radiating to front of chest. No blistering rash yet. Patient also reports itching and burning sensations in affected area. Patient went to urgent care (2/25/21) and was diagnosed with shingles. Patient was prescribed valtrex.

Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73

Have a round red circular mark the size of a silver dollar where injection was given. It is raised and painful and hard to the touch. Started the evening after receiving the injection, still have it 2 days later

Pruritic morbilliform rash upper chest and bilateral arms , shoulders to hands. Eventually spreading to pretibial region. Treated with OTC Claritin, Pepcid, Benadryl and eventually 0.5 % Triamcinolone cream. Rash resolved in same pattern that it appeared -chest arms and legs over a two week periord.

Arm was sore at injection site for about 24 hours then the next day severe arm pain started. Within a few days it was painful to move my arm backward, upward and forward. The pain lasted over a week; I contact Primary Physician and he recommended ice and acetaminophen. I did that for several days and by day 10 it was spreading to my shoulder area and radiating down my arm. On 2/25 I went to urgent care (primary is 50 miles) and then my Primary is preparing consult for Ortho.

high heart rate, muscle aches and pains, left arm still hurts, still swollen in areas. My arm flet like it had a fever at injection sight. I was pale in face.

patient reports mild facial itching and rash; limited to face only; no rash on trunk or extremities. no other complicaitons.

10:16am Client c/o feeling warm. Alert, and oriented x 3, Denies SOB, dizziness, and dyspnea. Pulse= 80. B/P=128/76. No thermometer available to take temp. 10:17am Client left at end of 15mins stating that she feels it is the mask making her warm and will drink water once she gets out to car.

4 inch area at injection site hard, red, hot. Extreme fatigue. Slight fever. Muscle and bone ache. Rash and itch on abdomen. Itch at injection site. Symptoms slowly decreasing over time, but not yet gone.

Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.

minor injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El324? (as reported)), via an unspecified route of administration at the left arm on 08Jan2021 at 13:00 (01:00 PM) at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no medical history. The patient had no allergies to medications, food, or other products. Concomitant medication included levothyroxine sodium (UNITHROID) that was received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor injection site soreness on Jan2021. The event was reported as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovered on Jan2021.

On the right arm all through tattoo surface a ?rash? appeared that was very itchy. No where else on my body did this occur. Treated with a steroid cream to calm the itching.

WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.

I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.

My husband also had the same vaccine at the same time but did not experience my symptoms as described below: Vaccination was given very high on the should blade instead of upper arm of left arm. After the injection on 2/27/21 arm was mildly sore, but on the third day, there was more pain. On March 3, the pain was worse, very painful to lift or bend left arm, constant throbbing pain, there is no inflammation on the injection site but whole left arm especially the injection site is very very painful. To this day, March 5, 2021 the pain and throbbing persists, It is very painful to lift or bend the left arm. Will start take OTC CVS Ibuprofen 200 mg every 6 hours to ease the pain.

Pt developed hives 19 mins. after receiving the vaccine. No resp distress noted, lungs clear, Benadryl 25 mg PO tab given. @ 4:12pm, Within 5 mins, hives began to subside. Pt stated she was feeing better. Observed for 30 mins more. Hives lessened significantly, and pt denied any other symptoms of acute reaction. and was released home. Husband drove pt home and she stated she would f/u with PCP. upon release. No distress noted.

8:00 am 3/3/2021 had severe muscle and joint aches. Area of injection was red all around in large area and warm to rich. Was lethargic.

Saturday evening injection sight started hurting. Woke up Sunday morning to nausea, dizziness, chills, muscle and joint pain, headache, tiredness

9 minutes after receiving Pfizer vaccination, while in the recovery area, c/o feeling of throat / tongue swelling, with noted redness in the upper neck region just below the chin. Able to speak without difficulty, denied SOB/pain or dizziness. Vitals were taken, WNL, AA0 x3, received ongoing monitoring. 911 was called as patient continued to c/o throat swelling, called at 1648, arrived @ 1658, patient was assessed, recommended transport to ED to ensure no further progression, patient declined transport, Husband was on seen at all time, agreed not to transport, waiver signed by patient. DC from recovery area @ 1705 w/Husband, ambulating freely and with clear communication/speech.

Little chill; tired; felt like I have no energy/ My body feels so weak; slight pain on left arm/ my hand started to pain a lot; I couldn't even touch my own self it was so sensitive; may be I'm inflamed; nausea; severe pain/ my waist my back is so painful; My body feels so weak; my fingers and hand; It triggered the shingles pain in my back; It triggered the shingles pain in my back; had no appetite, I didn't eat; She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: May2021), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization. Medical history included shingles which she contracted in 2019, about one and a half years ago, it was a shingles on her back and lower back which she stated were the worst place for shingles has attacked, it left her with severe pain in both legs; diabetes; and high blood pressure. Concomitant medications included losartan, atenolol (a beta-blocker), and metformin for diabetes. The patient took the vaccine on 22Jan2021 and after about 2-4 days (Jan2021), she had a little chill and got very tired. She had to take care of herself. She was very tired not realizing it was the shot she took. She also felt like she has no energy. The patient was working from home but a lot of times, she was lying on the couch. Over the weekend (Jan2021), she had a slight pain on left arm. About a week or 8-10 days later (2021), she got very tired and couldn't even sit up. Her body was not itself. She started to feel like a bus rolling over her, like somebody took a baseball bat and beat her really bad. The patient uses her arm a lot and her hand started to feel a lot of pain. She couldn't even touch herself; it was so sensitive. She took paracetamol (TYLENOL) but it didn't work. She had celecoxib (CELEBREX) an anti-inflammatory, she thought she was maybe inflamed, but it didn't work. She had some diclofenac cream, she rubbed it, but it didn't work. The patient had shingles about a year and a half ago which was very bad. She just felt weak and didn't feel like herself anymore. She had a little bit of nausea and her whole body was really terrible. When she had the shingles, it left her with severe pain in both legs. She saw a neurologist and told her that she would have to take pregabalin (LYRICA) and it would go away. So, when she had severe pain last week, she took pregabalin but it didn't help. The patient took half of acetaminophen, oxycodone (PERCOCET) as she was not the person who takes pills, but it didn't work. Her body was so severe on Friday, it was not going away, the pain was there 24 hours. The patient has been experiencing this for 8-10 days now. She took one PERCOCET on Friday and had a slight relief and didn't took anything again. She kept rubbing the diclofenac cream, but it was not much of a relief. This morning, she has to work, she was sitting so she took PERCOCET. She is getting her second shot on Friday, 12Feb2021. She asked how she will feel after the second dose if she felt that way after the first dose, if the first shot was adequate, and if she should take the second dose. She stated that she didn't want to take the second dose. Her body felt so weak including her fingers and hand. It triggered the shingles pain in her back and felt like she was beaten up by someone. She has to lie down for the pain in her back. She also mentioned that she couldn't sit for so long as her waist and back were so painful. She was lying on a heating pad and ice and nothing was working. She even has a hard time getting up. She thought what happened was it triggered the shingles pain in her back and also left her with a problem under her feet. The shingles left her with some kind of damage when she took the shot. It was really bad. Her son was a physician and was concerned because last week, it got so bad, she didn't come out, she was in bed and bedridden from Friday to Sunday. She had no appetite, she didn't eat. The only thing that the patient had was diabetes and high blood pressure, but it was under control. She just checked her pressure and its was 130/80, and now, because of the pain, it went up a little bit, but before my pressure was like 120 something, over 68 or 72 it was always around the 60s and 70s. Since she was having this, it was a little high. The outcome of the events was unknown.

My left upper arm was red, swollen, knotted for 9 days after my 1sf shot. The knot and swelling has subsided but the area is still red and itching.

Pfizer-BioNTech COVID-19 Vaccine EUA - injection site pain & swelling & redness, tiredness, monster of a headache, chills but no fever, another red, itchy, blotchy, painful area, about the size of a man's wallet, just below injections site (but, not connected to injection site redness).

Within minutes after receiving shot I became completely dizzy, lightheaded and started to faint. EMT came to my aid and took vitals all looked OK. I stayed in place until I felt better about 30 minutes. For the rest of that day and the next day I was extremely tired, a little nauseous, and kind of out of it. The third day I had very sore left arm at site and very sore and tender lymph notes on left side of Arm and trunk. Six days after the shot I came suddenly down with a massive headache and diarrhea. Al has since resolved and I am on day eight.

2nd dose of the COVID-vaccine administered on the morning of 2/18/21. Within the hour after administration, severe pain on left shoulder (site of administration) was experienced. Swelling, consistent aching pain, and limited range of motion/inability to lift arm over her head. Motrin for 2 days was self administered with improvement in severity of pain but recurred when Motrin discontinued. Motrin was taken as needed thereafter and was the pain continued until 2/26. Employee was followed up on 3/10 and verbalized that the pain had fully resolved. No further interventions.

Rash on lower arms (right and left) as well as the back of both calves. The rash is more like red sores that itch. Also developed peeling splotches on both palms that are extremely itchy. There are also spots of thinning, red skin by the nail beds on numerous fingers on both hands. These areas on the hands are also sensitive to hot water. Began appearing on 3/3/21. I was prescribed a regimen of Methylprednisolone 4 mg DosePack on 3/10/21 to alleviate itching.

After 1 hour facial swelling; After 45 minutes cheeks red; After 30 minutes face felt very hot; Stronger pain at injection site than with yearly flu shot; This is a spontaneous report from a contactable consumer (patient, self-reported). A 62-year-old female patient (who was not pregnant at time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, in Arm Left, on 25Jan2021 13:15, as single dose for COVID-19 immunization, at hospital. Medical history included Allergy to All pain relievers and anti-inflammatory drugs and over the counter, allergies to penicillin and Allergies to sulfites all types. Patient was not allergic to Keflex injections, but allergic to the pull form. Concomitant medications included amlodipine, fluticasone propionate (FLONASE), famotidine (PEPCID AC), calcium, colecalciferol (CALCIUM/VIT D) and one a day multi vitamin (within 2 weeks of vaccination). Patient previously took cefalexin (KEFLEX), Bacitracin, Neomycin, Lidocaine, Prednisone; had allergies with these all medications. Historical vaccine included influenza vaccine (FLU SHOT) and had Pain at injection site. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. After 30 minutes of vaccine, face felt very hot. After 45 minutes cheeks red. After 1-hour facial swelling. Took 1 Benadryl tablet after noticing swelling. Heat and redness then faded. Facial swelling reduced over the next 24 hours without more Benadryl. Stronger pain at injection site than with yearly flu shot, for which patient was not received treatment. Seriousness of the events was reported as non serious. Outcome of the events was recovered in Jan2021. Information on the lot/batch number has been requested.

Approximately 39 hours after immunization I woke with abdominal cramping. Upon standing I became light- headed and fell. My legs and arms turned red and warm and started itching. Itching subsided in an hour but redness remained for several hours. After itching stopped chills started and lasted several hours . By 7am symptoms were gone except for redness.

At time of injection, severe burning, bruising, and then a very large swelling/lump, redness/rash, and pain. At three days post vaccine now and redness/rash almost gone, swelling some diminished but still very present, pain some diminished but still present, and bruising still present.

Bilateral medial forearms - transient, mild, NON- pruritic, macular (no raised lesions), pink, mottled /levido-like appearance between medial elbows and wrists. First noted at home, 3.5 hours after vaccine. No other new signs/ symptoms anywhere else in body following vaccine. (No respiratory symptoms, no swelling, itching or obvious other skin color changes.) Due to no associated itch or other discomfort associated with the BL medial forearm mottling, I would not have known the skin color changes had occurred if I had not removed my long-sleeved shirt upon arriving home 3.5 hours after vaccine. Therefore I do not know at what point during the 3 hours post-vaccine that the skin color changes occurred. The pink BL forearm mottling appeared to be more pronounced and visible after showering upon arrival home, but then it completely and rapidly faded within the next hour (and was completely resolved by 10:00 pm, 5 hours after vaccine). No treatment used for it that night or since (no topical or oral meds applied or taken). It has not reappeared since. (It is now 5 days post vaccine.) Just reported to PMD office next day and had followup call this week. No other action needed or taken.

Developed hives 30 minutes after Vaccine, administered PO Benadryl observed an additional 30 min. and hives resolved.

Injection site arm hurt from shoulder down to my elbow. Not sharp pain, achy. I took 1 naproxen 500 which I use occasionally for my arthritis and it helped alot. It was still slightly achy until March 11, 2021.

Patient has allergies to several medications and keeps epipen on hand with her always. Was asked to sit for 30 minutes after vaccine. At minute 27 she started getting swelling and redness of her lips and face slightly. She normally takes Benadryl when this happens so gave her a Benadryl 50mg one dose. Her throat then became tight in a few minutes and she said that she needed an epipen because she was starting to have a little bit of trouble breathing. Gave epipen and her symptoms resolved within a few minutes. Kept her for 15 minutes. She stated that she knew she would be ok and asked if she could leave. I stated she needed to see the ER if she had any more trouble. I also consulted with her to check with her doctor about getting the 2nd dose because more than likely it's not recommended.

Rash on her torso (no hives, no elevations) 48 hours after her 1st shot of Pfizer vaccine. She reported this to her Oncologist and he recommended her to take the second dose in 3 weeks.

Shortness of breath; joint pain in hands; Headache; coughing with extreme pain and described a feeling of bugs crawling in her lungs, bugs front and back/ painful cough; itching; This is a spontaneous report from a contactable nurse. This case was also received from Pfizer sponsored program. A 62-year-old female patient received the 2nd dose (at the age of 62-years-old) of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# not provided), via an unspecified route of administration in Feb2021 at SINGLE DOSE for COVID-19 immunization. Medical history included lung and back problems (back pain). It was reported that the patient normally took an inhaler (not steroid inhaler because she didn't want to interfere with immune response), and other things. The patient previously took prednisone which started at 40mg for 2 days, 30 for 2 days, 20 for 2 days then goes down to zero for back pain (stopped taking 4 days before the second dose of the vaccine). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE (Lot# not provided) on 29Jan2021 (at the age of 62-years-old) for COVID-19 immunization. The patient's 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE was administered a week ago (Feb2021) Friday. It was reported that she got very ill initially which she said joint pain in hands and headache noted in Feb2021 (Saturday) which wasn't so bad. On Saturday afternoon, she reported shortness of breath, coughing with extreme pain (painful cough) and described a feeling of bugs crawling in her lungs, bugs front and back, and itching, and no one else reported it. The patient kept sleeping and waking up, thinking she was alright, but the coughing and lasted until Sunday evening, it was a very painful cough, and a creeping sensation in lungs front and back. She missed work on Monday. The events (joint pain in hands, headache, shortness of breath, coughing with extreme pain (painful cough) and itching) were medically significant as she was unable to go to work. It was also mentioned that since the patient stopped taking the Prednisone 4 days before the second dose of the vaccine. The patient had an exacerbation of pain (it came back). The patient was also wondering when can she start the inhaler and steroid for the back as she has lung and back problems. Outcome of the events were unknown. Information on lot number/batch number has been requested.; Sender's Comments: Based on data provided, the reported events are assessed as possibly related to BNT162B2. This case will be reviewed upon receipt of further information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient received the vaccine and about 3 minutes after she described a warm flushing feeling when it was injected, and tingling. No shortness or breath or chest pain, patient was removed from cell and taken to the observation area, her chest was red and flush. her blood pressure at 1145 was 178/122 and heart rate 89 and pulse ox 95% in her let wrist, patient was placed on litter and laid down, she was observed . Follow up blood pressure at 1208 on her left wrist was, 167/112, HR 87, pulse ox was 99 on room air. Blood pressure check in her right wrist was 175/99 . Patient stated that her symptoms were resolving with additional observation. Patient was then placed on the edge of the bed for additional time and patient was released from observation at 1215.

Soreness at injection site, and also swelling....both occurring on the second day after the injection.

After receiving my first Pfizer vaccine on 2.24.21 at 4:45 p.m., I felt well. I woke the next morning 2/25/21, and felt fatigue, arm was tender but not sore. Earlier that morning, I had an aura, but no migraine materialized. Around 10 a.m., I began to have chills, more fatigued, and sore muscles. Left work at 3 p.m. Arrived home, went to bed with temperature of 101.2. Took Tylenol. Friday, Fever was gone, felt fatigued, arm still tender, and had a headache. Took Tylenol. Did not go to work on 2/26/21. Saturday, 2/27/21, woke at 4 a.m., right arm where vaccinated was very sore, armpit very sore, and right breast very sore. Placed cool compresses on my breast, arm pit and arm where vaccine was given. Took Tylenol. Still fatigues, achy, with sore shoulder muscles. Sunday, 2/28/21, Vaccine arm still sore, with some soreness still in right breast area. Took Tylenol. 3/1/21, called Dr. Still a bit achy and arm still tender

Same day mouth and throat swelling, rash appeared several days later, not getting betting with steroids, Benadryl. Petechial rash diarrhea several days later.

A. 2-4 hours post dose: tiredness (may have been unrelated and due to lack of sleep and activity that day) B. Some buzzing in ears, and increased tinnitus (pre-existing) off and on up to ~ 24 hours post C. 4 hours post dose to current (24 hours post): Soreness in arm, at/around injection site, typical of other vaccinations (minimized bruising and soreness by rubbing arm during 15 min wait time to disperse serum and reduce bruising/ soreness); soreness increasing overnight ? feels much like exercise muscle soreness, still tender to touch at site at 30 hours post inoculation.

Approximately 15 minutes after vaccination, patient began feeling bumps on lip and swelling under jaw. Soon after, she felt flushed with itching in feet and swelling of feet. I observed a mild redness to face and upper chest. I saw no swelling of neck, lips or oral cavity. I ordered 25 mg. benedryl po be administered at 3:10 PM. A few minutes later, she felt tightness in chest. At that point (3:15 PM) an EMT tried to inject an Epipen but only left the pen in for less than 1/4 second before she withdrew the pen. I then administered another Epipen directly after and the pen was in her thigh for over 3 seconds. The patient was transferred light and sirens to ER. She received no further Epi in the ER and received steroids, benedryl, and famotidine according to the ER Resident. She was doing well 90 minutes after vaccination per Dr.

Itching starting at scalp progressed to lips, tongue, ears neck, chest , hands & legs. 2 Benadryl taken. Slightly itchy next day

Patient developed typical viral type symptoms ( felt foggy and "off") Saturday evening and woke overnight into Sunday with severe itching which lasted all day Sunday despite Benadryl and Pepcid and lotion. I saw patient Monday morning and she had hives on back, abdomen, arms, and some starting on legs. Given extent of hives, we administered IM steroid and prescribed Medrol Dosepak. No airway involvement. No prior history of reactions to vaccines. Will not know how effective steroids are as this is an urgent care, but she was feeling some improvement after sitting for 10 minutes after the steroid injection.

After 2nd dose (Pfizer EN6199, on 3/14/2021) I came to realize that the rash/outbreaks on my scalp started after my first Covid-19 vaccine. I was thinking it might have been caused by my use of drinking a tablespoon of the Olive Oil I started about a month ago. After it became worse in the last days, 2 days after my second dose and 6 days after had stopped with the Olive Oil, I think it might have been caused by the vaccine. I didn't change anything else. Same cosmetics and shampoo/conditioner for months.

Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart. Facility called 911 administered Benadryl via IV transported to ER Once in ED given Epipen at 2:21 and Decadron @ 6:05, discharged at 6:60 pm

These started 31 hours after injection. Chills, Headache, low grade fever of 99.9 body aches, sore arm. On 3 rd day after vaccine, injection site became red, hot to the touch and swollen. A separate area from the injection site also became red, swollen and hot to the touch. 4 th day, injection site and random site became more swollen and began to grow together with intense itching. Still hot to the touch and red.

Whole body is sore like as if I just ran a mile and every muscle hurts. shoulder/injection site hurts. Legs especially hurt.

started with rash on chest then became itchy everywhere, had shot Friday started benadryl Monday night

Itchy rash, small red bumps on legs, arms. From 2 days after vaccination, for 6+ days. Less itching after 4 days but rash still spread to hips , back and neck. Benedryl and Hydrocortizone cream. After seeing doctor, Zyrtec (OTC) and Triamcinolone Acetonide Ointment

Person administering hit a vein and blood was dripping down. Sore arm, lump and dark bruise 1.5? across at injection site. Fatigue and body aches beginning 4 days after vaccination.

Rashes over face, injection site 128/68, 100, 97, 100% H. Pt. alert and oriented X3. Rashes observed to injection site. Per EMS pt. will be transferred to Plantation for further evaluation.

About 4 hours after injection I started feeling pins and needles in my hands and then I started feeling it all over. It would come and go. A few days later it felt like burning, stinging and itchy. I?m still getting it but not as frequently. There?s no rash. I?m concerned about getting a 2nd vaccine. I know this could be related to the vaccine or anxiety. I saw blogs that this happened to others after the Covid vaccine.

Injection site still swollen on day 11 with large rash/redness. Urgent care doctor said it is Covid arm.

Pt experienced swelling immediately following injection. Pt was observed for 15 minutes following injection. After 15 minutes, pt left arm was red with a rash approximately 6 in in length. Site was warm to the touch. Pt denies pain or itching and denies any difficulty breathing.

Was sick for 1-1/2 days. Injection site sore for days. Had chills, just a general feeling of sick to my stomach.

tested positive for Rheumatoid Arthritis; body aches; muscle pain; joint pain; nerve pain; fingertips and toes were very painful-burning sensation; fingertips and toes were very painful-burning sensation; Underarm pain-throbbing; skin hurt when applying lotion; Low grade fever 99.9; This is a spontaneous report from a contactable other healthcare professional (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262), intramuscularly at right arm on 29Jan2021 11:00 at single dose for COVID-19 immunization at workplace clinic. The patient's medical history included autoimmune disorder, kidney disease, angina, and high blood pressure. There were other medications that the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Known allergies: Simvastatin, Tramadol, Codeine. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283), at the age of 62-year-old, intramuscularly at right arm on 09Jan2021 13:15 at single dose for COVID-19 immunization at workplace clinic. It was reported that on the 2nd day after the vaccine (30Jan2021 13:00) patient started having body aches, muscle pain, joint pain, nerve pain. Her fingertips and toes were very painful-burning sensation. Also reported underarm pain-throbbing. Her skin hurt when applying lotion. Had low grade fever 99.9. Treatment was received for the above mentioned events: Tylenol 500mg, 2 Caps Q6h. Patient was recovering from the above mentioned events. She do have an autoimmune disorder: her Rheumatologist is checking for Psoriatic arthritis. She had tested positive for Rheumatoid Arthritis (unknown outcome). No treatment for this condition at this time. The patient was not pregnant at the time of reporting, not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 or not prior to vaccination. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 at 2nd injection cannot be excluded for the reported events based on the known safety profile and the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About 6 hours after I got it, I felt tired. The next day, my arm was sore and my eyelids were swollen every day for about 5 days. I had aches and pain all over, itchiness, headache, joint pain over the next week. Around the 22nd, it stopped. It took almost 10 days for me to feel somewhat normal.

Swelling of the arm at the injection site, including soreness, and headache, fatigue, muscle ache, joint pain, slight fever - felt like I had the flu. Started overnight after the shot and lasted the entire next day. Treated with rest, hydration and Tylenol. Symptoms were gone by the following morning.

Triggered Trigeminal Neuralgia symptoms. 5 minutes after injection left shoulder sore. 25 minutes after injection left side of lips became numb. Medics responded, as we were talking, realized numbness had followed the trigeminal nerve back to the ear, and then from the ear, toward the nose. we determined it was not life threatening, and I was asked to contact my healthcare provider. Left lower quandrant of cheek/face was swollen for between 24 - 36 hours. Developed diarrhea 24 hours after injection.

After 24-48 hours my cheeks looked flush, after 72 hours it was darker and had prickly bumps, after 96 hours bumps more pronounced with some small pimple sized and covering a larger portion of the cheeks . It was also warm to the touch and beginning to feel like a mild sunburn. It stayed this way until Monday morning , 6 days later when I contacted my doctor. Doctor instructed me to take benedryl and see if this relieves it. Also informed me to take benedryl before I get my next injection. It is still ongoing at this level at the middle of day 6 as I am submitting this report.

Facial swelling, red hot cheeks. I took one Benedryl tablet and heat & redness subsided. 24 hours later swelling was gone.

Slight itching the day of the shot. As the days went on, the injection site got redder, itched more and felt hard. It reached the size of 3 inches across and about 2.5 inches tall. In addition, I'm feeling slight itching at different times at random places on my body. I refer to them as twitch itching. They itch briefly, and then another one starts somewhere on my body. The redness is still visible on my arm, but not to the degree it was. I am unclear if I should get another shot.

cellulitis; lymphadenitis; Fever 103; Still swollen from groin area down to knee; This is a spontaneous report from a contactable other HCP (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: not reported), via an unspecified route of administration in the left arm on 26Feb2021 at 12:00 PM at a single dose for COVID-19 immunization. Medical history was unknown. Concomitant medications were none. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient experienced fever 103 white posture on knee that turned into cellulitis and lymphadenitis. The patient had IV antibiotics twice within 5 days of vaccine as treatment for events. The patient still had swollen from groin area down to knee. AE resulted in emergency room/department or urgent care. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was not recovered. Information on the batch/lot number has been requested.; Sender's Comments: The event cellulitis is assessed as unrelated to BNT162B2 based on the information provided. The event onset date is not reported, therefore the drug-event temporal relationship is not clear. In addition, the BNT162B2 vaccine was administered in the arm but the reported cellulitis was at knee area. It is very unlikely that the cellulitis was related to BNT162B2.

high fever x 2 days, low grade fever x 1 day, fatigue, body aches, severe chills, shaking, brain fog x 4 days , injection site reaction - swelling and redness in entire L arm x 3 days, hot flashes with intense sweating.

Underarm swelling, redness, and pain - in armpit and down inside of left arm. Starting Saturday - started 1 day after injection and has gotten worse each day.

Felt dizzy, had metallic taste in mouth. Numbness & tingling of lips, tip of tongue. Dizzyness got better after 15 minutes. Tingling of lips & tongue better after 1 hour, but still present. Face felt hot & flushed 40 minutes after shot. Also had some "burning" of veins in wrist . Metallic taste continues.. Some itching of face.

No serious side effects after first dose. no fever, no tiredness. minimal site pain, very slight bump at injection site. gone within 24 hours. Second dose small side effects; very slight bump at injection site, pain upon firm pressure on 3 inch area surrounding lasting for 38-45 hours . about 21 hours after waking the next morning, had eye pain, dryness, gritty feeling, used eye drops with minimum success on relief. after 25 hours eyes feel hot, apply cool compress to closed eyelids, tried eye drops again, some relief. 27 hours started a small temperature of 99.7 - 100.1 for 2.5-3 hours, laid down to rest, improved although eyes were still a little irritated, dry, gritty, not hot. went to sleep, no further symptoms.

PT HAD RASH FROM PAST POSITIVE COVID TESTING. RASH INCREASED DRASTICALLY AFTER FIRST DOSE. RASH IS NOTED FROM NECK TO FINGERTIPS AND DOWN LEGS.

Pt states that she went this morning to get the Pfizer vaccine, 1st dose. a few hours later she developed rash, approx 17:00, two tiny little dots on her back and one larger one, abdomen. adv that for this very minor "reaction" she may take antihistmine like benadryl, topical hydrocortisone and analgesics as needed. if it gets worse call back for further recommendations. if serious effects appear call 911.

2nd vaccine rec'd on 03/20/21. On 03/21/21 still a lot of soreness in left upper arm. On 03/22 PM, noticed the armpit lymph nodes swollen and slightly sore to the touch. Symptoms same on 03/23. On 03/24/21, noticed a red rash on outer part of upper arm to the elbow. Sweats and chills in PM and 2 fever blisters appearing on moth on left side. Morning of 03/25/21, rash worsens, sweats and chills continue. Toward afternoon, lightheadedness and trembling in hands. Felt better after lunch, some lightheadedness, still.

Client c/o swelling on site vaccine given, LD and some pressure when swallowing. Client reports having a headache on first COVID-19 dose. Site assessed and no swelling noted on LD, nor pain reported. No swelling observed near throat area. Upon client departure at 10:30 am, client was able to move arm and speak/swallow with no difficulties. Client advised to contact PCP if any other issues occur at home. Client verbalized understanding. Client assessed by EMT and nursing onsite. All vitals within normal limits.

Initially light headed and sever headache. The next day, developed severe skin burning sensation all over body, including inside of mouth. This pain has increased as the days went on. This pain is severe, and continues into now 10 days. Dizziness and stomach upset has increased. Ringing in the ears and increased sensitivity to sound. Also experiencing weak and shakiness.

rash; hives; swollen face; congestion; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, via an specified route administered in Arm Left on 14Feb2021 10:30 AM at single dose, second dose via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Batch/Lot Number: ENG199) as SINGLE DOSE for covid-19 immunisation. Medical history included avn (left hip and both knees replaced), Known allergies: Bee stings, Cats. No covid prior vaccination. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT). No other vaccine in four weeks. The patient experienced Slight reaction from first shot: Rash, hives, swollen face, congestion. 10Mar2021 10:00 PM, the patient experienced same events after the second dose, resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient hospitalized for 1 day. The patient tested Covid post vaccination on 11Mar2021: Nasal Swab with Negative result. The outcome was recovering.

At 20 minutes from vacination my face became in flamed below the ear on both sides. Face became bright red. Heart rate was taken. Blood pressure was taken (said to be 182 over 95 - nomal runs 82). Was given one benydrl. which makes me drozy. After approximately 30 minutes heart rate lowered. I wasn't given the full information. Representatives identified themselves as CDC documented information. PCP was notified. I need to get a second vaccine, I need to be advised on how to proceed.

FELT FLUSH, DEVELOPES RASH ON CHEST. GIVEN IV DIPHENHYDRAMINE AND NORMAL SALINE BOLUS. DECLINED EMS AFTER RECEIVING ADVICE FROM ER DR, NP AND EMS

HPI: The Pt is a 62 year old female who presents with localized injection site swelling immediately after receiving her vaccination. Pt had 1st dose Pfizer to the right deltoid. She denies any pain at the injection site. Pt denies any Hx of allergic reactions or incidence of injection site inflammation in the past. She has a Hx of DDD, carpal tunnel syndrome, and nerve pain for which she takes Cymbalta and Celebrex. Pt also takes oral Prolia for osteoporosis. Pt denies any swelling of the face/lips/eye, difficulty swallowing, tightness of the throat, or itching of the skin. She also denies numbness or tingling in the bilateral UEs.

One week after injection, appearance of a mildly itchy red rash on arm near the injection site, approximately 2.5 inches.

Pt experienced lip numbness and tongue "thickness" between 5 and 10 minutes post-vaccine administration. She was brought to Observation are, vital signs checked and symptoms monitored. 1 dose antihistamine given at 1205pm. She then felt itchiness in throat and ears. 2nd dose po antihistamine given with complete relief of sx's at 1235pm.

Rheumatoid arthritis; little stiffness in her arm; she was not feeling very"/just felt little off; little pain in her left arm where the vaccination was given; pain in her elbow; seems like her left arm was swollen; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (lot number: EN6202 and expiration date: 30Jun2021) as 0.3 mL, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer Vaccine last Friday (05Mar2021) and on an unknown date, she had little stiffness in her arm and she was "not feeling very" (incomplete sentence), you know she was just felt little off but other than that, not too bad. The patient also had a little pain in her left arm where the vaccination was given and some stiffness on unknown date. Since then, she had pain in her elbow on left arm and today (10Mar2021), the pain was pretty persistent and seems like her left arm was swollen. The patient also stated "I guess I should say, I have rheumatoid arthritis" (pending clarification)". The patient received treatment for the events, stated "The only thing I took in this morning is Tylenol." Outcome of the events was unknown.

c/o severe itching at injection site that then extended to legs and both arms. Vitals: at 1040 BP 199/110, HR 68, RR 14, O2 SAT 100%, Alert/oriented. Pt given Benadryl 25mg@1042a, pt initially declined Benadryl 50mg po as recommended; A 2nd dose of Benadryl 25mg po was given at 1054a for worsening itching. Care transfered to on-site EMS, remaining Vitals per EMS. At 1100a INT placed to Lt AC area. At 1108a Solumedrol 125mg IV given per EMS for worsening itching. Paramedics arrived @ 1128 to transport patient; they departed to the hospital at 1129a in route to NSH Duluth.

Heart palpitations for 3 hours (11:30-2:30), dizziness, slight headache that morning, soreness at injection site. I left work early and went home to lay down. I took 2 aspirin. I slept for 20 minutes and woke up feeling better. My doctors office was closed since this happened on a Friday. I consulted with a friend that is a RN and she advised going to emergency room. I have horrible health insurance so I didn?t want to pay 650.00 to go to emergency room. I?m not sure I want to get the second shot since I have heard that adverse reactions increase with the second shot.

I developed Mononucleosis six weeks after my second dose of the Pfizer vaccine. Fever, severe night sweats, severe fatigue, loss of appetite, head aches, and blisters on my skin. I have not been exposed to Mononucleosis that I know of and have been isolated from the public because my husband had not been vaccinated yet. Mononucleosis has a 4-6 week incubation period which is when I took my second vaccine shot

Pfizer-BioNTech COVID-19 Vaccine EUA. Dizziness starting approx. 1 hour after shot; extreme fatigue and sleepiness occurred approx. 5 hours after shot. It is now 14-1/2 hours after the shot and I am still dizzy. I fell asleep for 3 hours. I'm still tired but not falling asleep at the wheel. Pain at injection site started approx. 7 hours after shot and still hurts.

Prickly rashes on ankle and back of thigh, started ~9 hrs after injection. I tried to describe rashes in detail, but was kicked out of site after spending time to describe them carefully. Plese call if you need more info

Outbreak of cold sores on chin, otc medicine - abreva or left alone, still ongoing - but usually lasts a week or less.

pain at injection site. nausea, chills, headache, joint aches, general unwell feeling. This started during the afternoon after receiving injection in the morning-Friday. This continued all the next day-Saturday. All was resolved by the following morning-Sunday.

Patient received 2nd vaccine. About 10 mins after administration she reported nausea, light headed, itching, rash, numbness. Patient requested to only have 25mg of Benadryl administered. Per Dr. ok to administer that amount. Benadryl 25mg IM in the left deltoid at 11:30 AM by RN

Red, swollen and soreness. Receive the shot on a Thursday and today Monday injection site if very red swollen and warm to the touch. Put ice on my are yesterday but it doesn't seem to have helped much

Hives on torso, both upper arms, right upper thigh, both wrists and hands; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 11Feb2021 15:45 (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included Diabetic, control cholesterol and allergies: Latex from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin, atorvastatin, glipizide; ciclosporin (RESTASIS) taken for an unspecified indication, start and stop date were not reported. The patient experienced hives on torso, both upper arms, right upper thigh, both wrists and hands on 11Feb2021 18:15. Therapeutic measures were taken as a result of hives on torso, both upper arms, right upper thigh, both wrists and hands and included treatment with Benadryl, cortisone cream. The outcome of the event was reported as recovering.

Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose

fluid like blister on roof of mouth, red dots on skin, extreme fatigue and worsening of arthritis symptoms and GERD

developed a severe body rash over my entire body; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self that the 62-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 10Mar2021 (Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included thyroid disorder from an unknown date and unknown if ongoing Other medical conditions: consumer stated, "No just thyroid." ( Further clarification unknown). Concomitant medication(s) included lurasidone hydrochloride (LATUDA) at 80 mg, once a day, oral for an unspecified indication, start and stop date were not reported; zolpidem tartrate (AMBIEN) at 6.25mg, once a day, oral for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) at 20mg, once a day, oral for an unspecified indication, start and stop date were not reported. The patient experienced developed a severe body rash over my entire body (hospitalization) on 16Mar2021 with outcome of unknown. Therapeutic measures were taken as a result of developed a severe body rash over my entire body. Reporter seriousness for have to go to the emergency room to get steroids to slow it down was Hospitalization. Consumer stated, "I had a reaction to the vaccine took vaccine ,I had it 6 days and I developed a severe body rash over my entire body." On paraphrasing concern: consumer stated, "This was the first shot, I had rash all over my body everywhere and I have to go to the emergency room to get steroids to slow it down, right, I am on Prednisone from 16March, I got shot on 10Mar and I got the reaction on 16Mar." Consumer stated, "That's what I want to report and do you know if have would have anything from having one shot my doctor won't let me take the second shot?" Consumer stated, "I have been on Prednisone since the 16th." ( Treatment in response to event), the Covid red rash, that's why they called me in hospital, when I went to hospital, I only I have this rash all over my body and it is slowly going away, I don't have thyroid I have rash all over my body."

passed out twice; Intense, rapid and irregular heartbeat (prolonged); intense pain in various organs and muscles (some short and some long duration); rash; cold; night sweat; no energy; intense dreams first night; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EP6955) via an unspecified route of administration, administered in arm left on 30Mar2021 13:30 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included zolpidem tartrate (AMBIEN). The patient was healthy. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient received the first dose of BNT162B2 (Lot number: EN6199) in the left arm on 11Mar2021 11:00 AM at the age of 62-year-old for COVID-19 immunisation. The patient experienced passed out twice, intense, rapid and irregular heartbeat (prolonged), intense pain in various organs and muscles (some short and some long duration), rash, cold, night sweat, no energy, intense dreams first night; all on 30Mar2021 with outcome of not recovered. Doctor appointment was scheduled. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether treatment received for the events.

Suspected vaccination failure; Mild Shingles symptoms / after my first Covid vaccine on 4/16/21; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, TOZINAMERAN (COVID-19 VACCINE PFIZER) (batch number ER2613, expiry date unknown) for prophylaxis, estradiol vaginal for drug use for unknown indication and estradiol + norethisterone acetate (Combipatch) for drug use for unapproved indication. The patient's past medical history included esophageal acid reflux and shingles (experienced one severe case and one mild case of shingles 10 years ago before the date of reporting, when patient was at her mid 50's). Previously administered products included Zostavax (received on 9th January 2015). Concurrent medical conditions included food allergy (Raw shrimp allergy), allergy to antibiotic (Sulfamethoxazole TMP DS 800-160 mg Tablet), drug allergy (vioxx) and fruit allergy (fresh pineapple). On 1st December 2018, the patient received the 2nd dose of Shingrix. On 2nd July 2018, the patient received the 1st dose of Shingrix. On 16th April 2021, the patient received the 1st dose of COVID-19 VACCINE PFIZER. On an unknown date, the patient started estradiol vaginal at an unknown dose and frequency and Combipatch .05 mg at an unknown frequency. On 16th April 2021, 867 days after receiving Shingrix and 1019 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The action taken with estradiol vaginal was unknown. The action taken with Combipatch was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. Additional details were provided as follows: The ethnicity information and race information was available but not provide. The patient received the two doses of Shingrix,one dose of Covid-19 vaccine on left arm and within 2 weeks of Vaccination patient received estradiol (Vaginal Tabs 10 mcg,) and combipatch (0.05-0.14mg) and later patient experienced mild Shingles symptoms on left side of abdomen and left side of back. The patient had no Shingles side effects until 8 hours after her first Covid vaccine The patient did not received any treatment. The patient was not tested or diagnosed with COVID-19. It was unknown if the reporter considered the shingles to be related to Cocid-19 vaccine, estradiol vaginal tablet and combipatch. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.

Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.

felt low blood pressure; weak; confused; When fell hit self on head, lip, nose, and eye; When fell hit self on head; bruises on face; had burst lip; diarrhea; leg pain; fainted; seizure; felt hot; chills/shaking.; This is a spontaneous report from a contactable consumer (patient herself). This 62-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unspecified route of administration in the left arm, on 13Apr2021 at 21:00 (at the age of 62-year-old) as single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EP6775 MS 389) administered via an unknown route in the left arm on 17Mar2021 (at 10:00 AM) for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included gastritis and anxiety. Past drug history included allergy to mirtazapine (REMERON). Relevant concomitant medications included diazepam (VALIUM), vitamins and probiotics. On 13Apr2021 at 23:00 the patient had chills / shaking. On 14Apr2021 at 02:00 AM, she felt hot. She went to bathroom, felt low blood pressure, weak, and fainted. Woke up, felt disoriented, not know where she was, confused. When fell hit self on head, lip, nose, and eye. She suffered various bruises on face. May have had seizure, had burst lip and felt was biting. Then suffered diarrhea that day. She also experienced leg pain. She went to the doctor on 16Apr2021. On unknown date, blood work up was done and results were not provided. The patient was recovering from the events. Information on the lot/batch number has been requested.

hives on face; facial flushing; swelling of lips, tongue and throat; swelling of lips, tongue and throat; swelling of lips, tongue and throat; known allergy clearly the Pfizer Covid vaccine; This is a spontaneous report from a contactable consumer. A 62-year-old female consumer reported that she received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) intramuscular into the left arm on 01Apr2021 at 09:00 am (at the age of 62-year-old) at single dose for COVID-19 immunization. Concomitant drugs included vitamins only. Known allergies included all shellfish, Percocet, adhesives on bandages. On 01Apr2021 at 09:15 am the patient experienced facial flushing, hives on face, swelling of lips, tongue and throat. As per reporter the AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The patient was treated with IV with epi, solu-medrol, prednisone and Benadryl. The patient reported as known allergy 'clearly the Pfizer Covid vaccine'. The patient recovered from the events on an unknown date.

injection site soreness, red rash, itching; injection site soreness, red rash, itching; Injection site soreness; This is a spontaneous report from a contactable Healthcare professional (Patient herself). A 62-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9263, Expiration date: Not reported), via an unspecified route of administration on 16Feb2021 03:15 PM at a single dose at her left arm for COVID-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included losartan, tocopherol (VITAMIN E), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), estradiol (YUVAFEM) and replens iron, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site soreness, red rash, itching on 18Feb2021. No treatment received for the adverse event. The patient had not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information about batch number has been requested.

I first felt dizzy and tingling around my lips and mouth about 5-10 minutes after the injection, waited a bit hoping it would go away and when it didn?t we alerted the EMT on site. My lungs sounded ok so I was instructed to go home and take Benadryl. On the way home my tongue began to swell and get a tingling sensation. My cheeks became extremely hot and had a red rash. I ended up having to take two Benadryl to get the symptoms to go away.

Pt woke up day after vaccine with itchiness on her chest, throughtout the day the itching did not go away. Woke up Wednesday with rash all over chest area. No rash elsewhere on body. Reported to employee health and was told to take benadryl and if rash continued to contact my primary care provider.

Two days after vaccinated, injection site became red, swollen, and slightly itchy. Looked like a large welt. It is getting better today, 1/3/2021.

Tightness on the chest Blood Pressure was high 185 or 198 Dry Mouth Hard time to breath After 1 hour I started itching

significant fatigue; temperature was taken when waking up - 101F orally; she slept more; localized injection site pain and redness; localized injection site pain and redness; This is a spontaneous report from a contactable nurse (patient). This 63-year-old female Nurse reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular at right arm on 17Dec2020 08:30 PM at single dose for COVID-19 immunization. Facility type of vaccine was hospital. Medical history included shingles in Jun2020 after illness that mimicked COVID-19 but all tests came back negative - was sick for 3 weeks; no other chronic health conditions; severe beef/pork allergy - anaphylaxis. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications were not reported. No other vaccine in four weeks. On 18Dec2020 02:00 PM, patient experienced significant fatigue; she slept for 1 hour and temperature was taken when waking up - 101F orally; she slept more; she had localized injection site pain and redness for 3-5 days. No treatment was received for events. It was reported as non-serious. Outcome of events was recovered in Dec2020.

Pt has a mild rash that covers the injection site and large parts of the chest. Pt advised to take allergy medications

right mouth drop; right face numbness from eyebrow to below chin with right mouth drop; pins and needles feeling at injection site; then ears itching; This is a spontaneous report from a contactable nurse, the patient. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EK9231), via an unspecified route of administration, on 30Dec2020 at 03:45 AM (at the age of 63-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a workplace clinic and anatomically located on the right arm. Medical history included: History of Guillain Barre in 1970's with Swine Flu Vaccine. Concomitant medications included: clonidine (MANUFACTURER UNKNOWN), hydralazine ((MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN); all for unknown indications from unknown dates and unknown if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took unspecified medications (MANUFACTURER UNKNOWN), from unknown dates to unknown dates for unknown indications and experienced sensitivity to some medications, and unknown if ongoing. On 31Dec2020 04:15 PM, the patient reported "Within 30 minutes of vaccine, I had pins & needle feeling at injection site. Then ears itching followed by right face numbness from eyebrow to below chin with right mouth drop." The patient did not receive any treatment for the events. The clinical outcome of the events pins & needle feeling at injection site, ears itching followed by right face numbness from eyebrow to below chin with right mouth drop, was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the temporal association.

My trunk area starting itching. I developed a fine rash on chest/ abdominal area. A few hive like weals appeared on abdominal area. No other symptoms. I took Benadryl 50 mg . After a while itching subsided. No further issues.

Temp of 102 with chills and body aches and pains, incision site of left ORIF became red and inflamed and I had to go to the emergency room where I was given doxycycline b.i.d. for seven days.

This is a self report: two days after the vaccine I developed severe heart burn ( something I have never experienced). Several over the counter medication were used without relief. . The heart burn was followed by a horrible gastric disturbance. I experienced abdominal pain, cramping and rectal pain. During this time my temperature remand between 100.0 - 101.0 with fatigue and malaise. I have also noticed several welts on my body. I?m typically a very health person and have never experienced any of these experiences before.

Within 8 hours of vaccine receipt, I began to experience left-sided tinnitus. During the first vaccination; I experienced muscle soreness at the site of injection; mild fatigue the next day (12/14/2020). After the second vaccine, I experienced increased muscle pain, with decreased ROM of the left shoulder due to pain. Within 12 hours, I experienced diffuse myalgias. After 16 hours, I experienced a fever (101F) with chills (resolved within 24 hours). There was significant fatigue the first 36 hours after the second vaccine administration. I took two doses of Tylenol on the first day. No rash.

Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; Hives from her head to her toes, intense itching, painful, swollen ears, swollen lip; This is a spontaneous report from a contactable Health Care Professional (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK572) in the left arm, on 21Dec2020 at 11:30 AM, at single dose, for COVID-19 immunisation. COVID-19 vaccine was administered at hospital. Relevant medical history and concomitant medications were unknown. The patient had not received any other vaccines within 4 weeks and 2 weeks prior to the BNT162B2 vaccine. The patient experienced in the past an allergy due to amoxicillin. On an unspecified date, the patient experienced hives from her head to her toes, intense itching, painful, swollen ears, swollen lip. Emergency room/department or urgent care required. Treatment was received: prednisone 60 mg for 5 days. The patient recovered from the events on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test post vaccination (nasal swab) was performed on 25Dec2020 and the result was negative. The case was assessed as non-serious.

Urinary tract infection; Injection site soreness/ Injection site pain; Achy; Headache; Sore on the injection arm; Her arm was stiff feeling; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL0140), intramuscular on 18Dec2020 15:00 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The transferring agent stated that she has a caller on the line that received the first dose of the Covid-19 vaccine on 18Dec2020. She is supposed to get the second dose tomorrow 06Jan2021. She developed a urinary tract infection over new years and was put on antibiotics. She wanted to know if she could get the second dose while on antibiotics. The transferring agent stated that the caller reported that she started feeling achy and had a headache, but did not think it was related to the shot. She stated that she had injection site pain and was sore on the injection arm. She had the shot late in the afternoon around 15:00 on 18Dec2020. She said that she was sore later on that evening at the injection site and her arm was stiff feeling the next day, but it was resolved by the day after. She said that the headache came and went. She treated it with Tylenol. She said that she did not feel real good most of the day on Saturday 19Dec2020, but by Sunday she was back to normal again. The outcome of the event Urinary tract infection was unknown while the outcome of the other events was resolved on 20Dec2020.

Injection was given very high on my L arm. Vaccinator said she had difficulty injecting vaccine-taking about 15 seconds to complete injection. Injection was painful. Within 1 hour I could not raise my arm more than 30 degrees without severe pain. Diminished ROM and pain at night is ongoing. Within 4 hours, I had a low grade fever with chills, headache and myalgia that persisted for 12 hours then respoved. I am awaiting an appointment with my primary care physician and will know then if more treatment will be recommended. Incident Report filed at the hospital.

Hard, pounding tachycardia, with dizziness, nausea, headache, occurred about 5 minutes after vaccine was administered. The tachycardia resolved without medical intervention within 2 minutes. The remainder of the symptoms remained the rest of the day, along with profound fatigue and intermittent self limited tachycardia. The headache was managed with Tylenol. I slept most of the day and through the night. The following day, I had a headache, which was mild. Fatigue remained. I also noted intermittent tachycardia with mild exertion, self limited, less than 1 minute. Mild soreness at injection site.

Patient woke up Saturday am and right foot felt like it was sprained, painful at ankle joint, slightly red. Sunday morning, she could not put any weight on right foot, more red/all toes red (except one), redness is traveling down right big toe, right foot appears slightly swollen.

On 1/9 /21, after walking 5 miles and taking a hot shower I had large welts that were red on the inside of both thighs. Within 1 hour they were gone and did not return.

complained of vague complete LEFT arm Itching with NO others symptoms ; vitals stable; refused further treatment; itching completely resolved on it's own in the next ten minutes and pt. left to go home.

After receiving second covid vaccine, injection site is red with a circle larger than 2 inches (4 by 6 inches). Symptoms include runny nose, headache, fever and are ongoing since vaccine. Have not visited healthcare professional yet.

I received my second vaccine uneventfully and approx. 2 1/2 days later I developed a painfully and swollen lower lip , and then it had severe erythema , pain and ulceration . I have never had a cold sore in my life, or shingles . I did receive the chicken pox vaccine in my 30's

Large Erythematous area at injection site. Tender and bruising noted Low grade fever. General not feeling well

Soreness injection site; The initial case was missing the following minimum criteria: unspecified product and adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 23Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy and anaphylaxis to a penicillin type drug. The patient's concomitant medications were not reported. The patient previously took ampicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy. On 23Dec2020, the patient experienced soreness at injection site. The patient did not receive any treatment for the event. The clinical outcome of the soreness at injection site was recovered in Dec2020 after about 48 hours. The reporter considered that there was a reasonable possibility that the soreness at the injection site was related to the vaccine. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

I developed a swelling in the right axilla, not a discrete node, but what felt like an accumulation of fluid - lymph perhaps - about the size of a large lemon.

Muscle soreness, injection site pain/swelling, tongue numbness, fever, headache and violent tremors to all extremities (for about 10 mins) and chills the night after getting the vaccine. tongue numbness happens to her at baseline at times, this has subsided The tremors started after stretching her arms, they stopped shaking after about 10 mins after she laid in bed. Temp was about 100-101.2 through the night Has not taken any medications for this.

temp of 101.8 at 11:00pm on 1/11/2021. Woke up at 4:00am on 1/12/2021 with muscle cramps in both legs; aching all over and headache and body aches ; fatigue and extreme muscle tenderness in left arm (site of injection) Temp remained at above 100.0 even with Tylenol and headache and body aches until 9:00pm. Woke up on 1/13/2021 with only symptoms being sore arm; slight headache and muscle tightness in neck.

Developed fever and headache then later developed hives, itching, and bruising. Already taking Zyrtec daily. Began taking famotidine daily. Required Benadryl on 1/11/21 but still has hives as of 1/11/21.

Initially muscle soreness at injection site. At 12 hours headache began. During the night body aches and restless sleep, bad dreams. Next day headache, significant fatigue and body aches. Emotional feelings like I wanted to fry ( I am not a crier). 2 Nd night restless sleep, bad dreams, headache. Next day brain fog and significant dizziness and vertigo.

On Friday, January 15 at approximately 6 PM while seated in a reclining chair watching television I started to develop hives below my right gluteal fold. Over the next six hours approximately 300 hives appeared on my skin. They were very itchy. At approximately midnight my lip began to swell and being a certified registered nurse anesthetist, who lives alone, I knew it was time to head to the ER. Prior to going to the ER I cleaned the lesions With alcohol, took prednisone 10 mg PO, and applied hydrocortisone cream. In the ER, I was given Benadryl 50 mg PO and Pepcid 20 mg and observed for one hour. The hives remained but there was no respiratory compromise. Approximately six hours later the hives were still increasing in size and number, were unbearably itchy and my swollen lips had not subsided. I took Claritin 10 mg PO and returned to the same ER and was given Epinephrine 0.3 mg IM, prednisone 20 mg po and observed for three hours. The hives did not decrease and again there was no respiratory compromise so I was sent home on prednisone And a H-1 blocker. Of note, both my palms and lips have been bright cherry red. I finished a five day course of Macrobid on January 13 at 10 AM. Final diagnosis: Alergic reaction

One and a half days after inoculation, itchy rash appeared on abdomen around naval area and at injection site . This lasted a couple days. Then on day 4 after vaccine, hives appeared on upper legs , then migratory hives and urticaria all over most of my body. Improvement but not completely resolved after 7 days.

Swollen lips started on 1/16 Redness, rash. on face noticed on 1/17 in am upon waking up. Swollen lips continues.

Fatigue; low grade fever; reddening on her face on the nasal labial area or smile line area; a very sore left arm for a day; a very sore left arm for a day and swelled up a little; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 19Dec2020 16:15 at SINGLE DOSE for COVID-19 immunization at the hospital. It was reported that the patient was menopausal. Ongoing medical histories included gastrooesophageal reflux disease (GERD), iron deficiency (reported as iron supplementation), sinus disorder, hypersensitivity; and hair disorder, nail disorder and immune system disorder (reported as help with hair and nail and immune system). Ongoing concomitant medications included fexofenadine hydrochloride (ALLEGRA) since unknown date (reported as taking for a year) for sinus and allergies, calcium (CALCIUM) since unknown date (reported as taking for a year) for menopause, famotidine (FAMOTIDINE) since unknown date (reported as taking for a year) for GERD, cyanocobalamin (VITAMIN B12) since unknown date (reported as taking for a year) to help with hair and nail and immune system, colecalciferol (VITAMIN D 3) since unknown date (reported as taking for a year or two) for menopause and multivitamin since unknown date (taking for 5 years at least). The patient received the first dose of the Pfizer COVID 19 vaccine on 19Dec2020 at 1615PM in the left arm. She then reported of a very sore left arm for a day and it swelled up a little on that same day. She then felt some fatigue a little the next day (20Dec2020) on Sunday but it didn't prevent her from going to work. On 20Dec2020 to 21Dec2020 (Sunday to Monday), she noticed a low-grade fever for a maybe 12 hours but she couldn't find a thermometer and doesn't know her temperature. She also developed a reddening on her face on the nasal labial area or smile line area but not very pronounced on 20Dec2020 (noticed it for about 8 to 12 hours). All of her symptoms resolved by the 21Dec2020. The events does require a visit to physician office or emergency room (ER).

redness, itching swelling, warmth at site, muscle aches, fatigue evaluated by MD, tx with pepcid, Tylenol, Claritin,Zyrtec began 01/19/2021 with mild relief

The following day after patient received 2nd dose of Pfizer vaccine, the area around the injection was light red, warm to touch and painful. The area was approximately 2.5 inches around. On Sunday 1/10 it was bright red, indurated, hot to the touch and much more painful. It was also painful to move his arm. On 1/13, the injection site was still tender to the touch and his shoulder area was sore with movement. Over the next couple of days his shoulder into his bicep had a dull ache and was very painful to any pushing, pulling or weight bearing. Ibuprofen did help but did not relieve it. On 1/17 patient went to a local urgent care because at that point it was even difficult to sleep due to pain. They diagnosed him with bursitis of the left shoulder due to SIRVA. He was started on a steroid pack and today, day 2 of steroids it feels slightly less painful.

itching across shoulders /back of neck; nausea; body aches; chills; She felt like there was a tight band around chest.; sense the she couldn't get a good breath; pulse of 101-129; she had tinnitus, and she noticed that both injections made that worse; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK4176/expiration date) dose number 2 intramuscularly on 08Jan2021 11:45 at a single dose on the left arm for COVID-19 immunization. The patient received the vaccine in a hospital. Medical history included severe allergic reaction to pecans and tinnitus. Historical vaccine included BNT162B2 on 18Dec2020 (dose number 1, intramuscularly on the left arm) for COVID-19 immunization. The patient experienced tinnitus, sinus infection, and stuffy head after the first dose. No other vaccines were administered within 4 weeks and no other medications were taken within 2 weeks. The patient was not diagnosed with COVID prior vaccination and was not tested for COVID post-vaccination. On 08Jan2021, after the 2nd dose, the patient experienced itching across shoulders/back of neck and sl nausea. She took Benadryl which relieved the itching. She went to bed and had onset of body aches, chills, and sense the she couldn't get a good breath. She felt like there was a tight band around chest. Her O2 Sat was 95% - 98%, with pulse of 101-129, T max was 101.8. The symptoms were lasting about 6 hours. In the morning, the patient took Aleve and Benadryl. Most symptoms were alleviated. She took those meds scheduled for 48 hrs. She noticed that if she tried to push past scheduled time, the itching started to return, so she just kept the meds scheduled for 48 hours. No other symptoms after that. She added that she had tinnitus, and she noticed that both injections made that worse. It was not yet subsiding since last injection. The patient also received Tylenol for the events. The outcome of the events was recovered in Jan2021.

Body aches, very sore injection site, tired feeling, nausea, slight headache. I had the chills, couldn?t get warm. Got worse during the night. Couldn?t go to work the next day due to body aches, arm soreness, extreme tiredness. Slept almost all day 1-19-21. Spiked low grade fever during the night. Worked 1-20-21, but extremely sleepy. Injection site got hot and red. Slept 12 hours that night. Went to work 1-21-21 feeling good, just still a little arm soreness.

Diarrhea, nausea, abdominal discomfort, injection sight was very sore. Anti- diarrhea over the count medication taken. Bed rest for 2 days.

Itching on the left arm near the site of the injection. area covered over 3-4 inches in length to 2 inches in width. red and hot. Notice on 1-21-21 around 10pm, could not find my anti itch cream to apply to site. Next day on 1-22-21 notice it again around 11 am it was red and hot to touch. Itching again. but I would not scratch it . Finally found the anti itch cream and applied this to the area. An hour later it was still hot but seemed to look better. Still trying to get to the hospital Clinic to have it checked out.....

hives covering entire body including soft palate, headache, body aches, stiff joints, fatigue Depo medrol injection, Prednisone 20 mg/day X 4 days; Zyrtec X 12 days, Benadryl X 12 days

Caller states she received her vaccines 9 days ago. 2 days ago she developed a rash under her right arm that is described as fine bumps that are itchy. The rash has now spread to both thighs. She denies other symptoms. She is going to call her PCP for appointment or instructions.

Extreme bone pain, joint pain, hand pain, skin tenderness, headache, nasal stuffiness, chills. Extreme pain lasted from 0140- 0500, but continued with the skin tenderness, chills, headache and joint pain. Took Tylenol. Got up once and thought I would pass out. Started resting some around 7am. Drank plenty of fluids. Drained all day. Saturday morning headache, nasal congestion, joint pain, hard to get out of bed. Drained all day. Sunday feeling better, but lethargic. Monday back to work.

Injection site pain, tiredness, headache , muscle pain, chill, joint pain, nausea, feeling unwell, swollen lymph nodes, difficulty breathing, swelling of face, fast hearbeat, bad rash , dizziness and weakness, intestinal pain. All symptoms lasted 18 days. Was given prescription medication for symptoms by primary care doctor.

Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, rash over right eye across inter canthus to lower lid, redness inner right eye, and slight rash right nose.

right arm sore, 3 days later right arm and hand starting swelling and developed rash with itching, also left hand swelled, with rash and itching. Next day woke up with sore throat and headache, and fatigue. went to primary care doctor was put on prednisone, symptoms lasted for 10 days.

Arm pain at site; Fatigue; Nausea; Body aches; This is a spontaneous report from a contactable nurse reported for herself. This 63-year-old no pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Et1685) intramuscular on 11Jan2021 13:15 at single dose for an COVID-19 immunization. Medical history included high blood pressure. Concomitant medication included atenolol Atenolol, Losartan, Calcium, plantago ovata (METAMUCIL), bifidobacterium lactis (PROBIOTIC). Patient received the first dose of BNT162B2 intramuscular in left arm on 21Dec2020 03:30 PM. No other vaccine in four weeks. On 12Jan2021, the patient experienced Arm pain at site, Fatigue, Nausea, Body aches. No treatment received. The outcome of events was not recovered.

Soreness at injection site for 72 hours.; Low grade fever 99.6 orally on day 3.; GI upset for 3 days; Migraine headache on day 6.; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231; expiry date: unknown) via an unspecified route of administration in the right arm, on 30Dec2020 at 11:00 A.M., at a single dose, for COVID-19 immunization. Relevant medical history included high blood pressure (BP), seasonal allergies, migraine, asthma, right sided hearing loss. The patient was taking unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 01Jan2021, at 8:00 A.M., the patient experienced soreness at injection site for 72 hours. On day 3, the patient had low grade fever 99.6. On an unspecified date in Jan2021, the patient had gastrointestinal (GI) upset for 3 days. On day 6, the patient experienced migraine headache. The patient did not receive therapy for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.

I began breaking out in a rash on the right side of my face. Thinking it was the mask I had worn. Now the rash all over my face and chest

2 days after 2nd dose, when bandaid removed, skin was broken on approx quarter-sized blister at injection site. Large amt (sleeve wet & serous fluid dripped down arm) serous fluid drained. Add'l pea-sized, intact, fluid filled blister present beneath 1st blister. Non-intact blister continues to weep am. amt. Serous fluid 12 hrs later. Injection site mildly reddened and swollen. Arm sore, but no excessive pain.

2 days after the injection she developed an itchy rash around the injection site. Symptoms are improving.

1. Patient had sudden bilateral thigh rash ( vasculitic like, bright red, softball sized) that she noticed 2 hours after vaccination, and lasted for another 3 hours then went away without intervention. 2. Patient had shingles flare on Left Maxillary branch, starting 2 days after (1/10/2021). She took acyclovir for one week (800mg five times daily). After four days of completing this antiviral course, she had a left mandibular distribution of shingles sensation, was placed on a week of valacyclovir 1 gm TID.

8/10 chest pain radiating into left arm; 8/10 chest pain radiating into left arm; tightness in chest; tightness bilateral flank area; HA; body aches; diaphoresis; hot feeling; numbness tingling of head; numbness tingling of head/tingling in jaw and over the top of my head; pressure in the back of my neck; blurred vision; This is a spontaneous report from a contactable nurse. A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration in right arm on 14Jan2021 10:00 at a single dose for covid-19 immunization. Vaccination was done in a hospital. Medical history included HTN, GERD, constipation, ocular migraine, osteoarthritis in sacroiliac joints, small fiber neuropathy, glucose intolerance, steatotic liver, CTS (Carpal tunnel syndrome). Concomitant medication included losartan (LOSARTAN), furosemide sodium (LASIX [FUROSEMIDE SODIUM]), and spironolactone (SPIRONOL). The patient previously received the first dose of bnt162b2 on 24Dec2020 10:00 AM for COVID-19 immunization. On 14Jan2021 11:00, the patient experienced tightness in chest tin which the patient took benadryl 25 mg with improvement, tightness bilateral flank area, HA, body aches, diaphoresis, hot feeling, numbness tingling of head, pressure in the back of my neck, and blurred vision. On 15Jan2021, the patient had an 8/10 chest pain radiating into left arm subsided after 10 mins, tingling in jaw and over the top of head, chest tightness and tightness in both flanks most of day 2. The outcome of the events was not recovered.; Sender's Comments: Based on the compatible time association, the possible contribution of suspect BNT162B2 administration to the event chest pain cannot be excluded. The status of medical history including HTN, GERD, constipation, migraine and osteoarthritis in sacroiliac joints would be helpful for further assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

My face got red and warm. A single hive developed on my left jaw. After a few minutes later my throat and tongue started to feel numb like I had gone to the dentist and gotten a novacaine shot. We went to a pharmacy immediately and got some Bennedryl which took the symptoms away within the hour.

Redness, rash on face and neck; Redness, rash on face and neck; Redness, rash on face and neck; Redness, rash on face and neck; Swelling of lips; This is a spontaneous report from a contactable pharmacist (patient) reported for herself. A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) intramuscularly at right arm on 12Jan2021 at 11:45 AM for COVID-19 immunization. Medical history included known allergies included amoxicillin, cephalosporins, sulfa, griseofulvin, unknown excipient in a generic ibuprofen. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685) intramuscularly at left arm on 21Dec2020, at 11:00 AM for COVID-19 immunization. No other medical history. No other vaccine in four weeks. Other medications in two weeks included multivitamin, fish oil (OMEGA FISH OIL), and collagen tablets. Facility type vaccine was at hospital. The patient was not pregnant. The patient received adverse events included swelling of lips started on 16Jan2021 at 02:00 AM (4 days post vaccine), redness, rash on face and neck started on 17Jan2021, with continued swelling of lips. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment received for events included instructed to take cetirizine hydrochloride (ZYRTEC) 10 mg 2 times a day plus diphenhydramine hydrochloride (BENADRYL) at night. The outcome of event swelling of lips was not resolved, and of other events was unknown. No covid prior vaccination. No covid tested post vaccination.

heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization. Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER). The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.

10 hours after my vaccine I got a rush of heat to my feet...felt like they were swelling. Tingling & numbness followed & also went to my hands. 9 days later I still have some residual tingling, mostly in my feet.

Itchiness in arms and shins, 50mg of Benadryl given orally. Symptoms improved, no new symptoms developed.

The employee received 1st dose of Pfizer Covid-19 vaccine at 14:00 pm 1/28/2021. About 5 minutes after receiving the injection, she felt itchiness of the ears, facial flushing and developed neck hives. She was taken to the MSB emergency room, where she was closely monitored. There, she was given dexamethasone 6 mg IM once, diphenhydramine 50 mg orally and famotidine 20 mg orally once. After about 2 hours of observation, he was discharged home on the following: prednisone 40 mg orally daily and diphenhydramine 25 mg q8h PRN.

Adverse effects not common. Skin itchy, skin sore , raw feeling, all over body...No rash or redness. Started eve of vaccine. For 2 days now / present

2:30 AM 1/30/21 chills, skin sensitive to touch, fever, extreme headaches, dizziness, nausea, redness at site of injection

Sore arm at injection site; Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL1284), via an unspecified route of administration in the left arm on 13Jan2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included Sjogren's Syndrome, connective tissue disorder, high blood pressure, was pre-diabetic, and had a known allergy to penicillin. The patient had other medications in two weeks (unspecified). The patient was not pregnant, had no other vaccines in four weeks, and did not have COVID prior to the vaccination. The patient experienced sore arm at injection site on 13Jan2021 at 21:00. The patient did not receive any treatment for the events. She was not COVID tested post-vaccination. Outcome of the event was recovered.

The time of my COVID 2nd vaccine was around 12:58 pm on 01/30/21. I started noticing blurred visions and some tingling at the injection site about 30 minutes after vaccine. Around 9:00 pm I started feeling weak and muscle aches all over, so went to bed. Around 2:00 am on 1/31/21 I woke up in pain all over my body muscle ache, headache, and difficulty walking. Took temperature 99 and my average temp is 97.9. I took one extra strength Tylenol. On 01/31/21 I just felt bad all day felt like COVID symptoms but no breathing difficulties just bad headache all day, weakness, entire left side my body left arm, left side chest, left leg hurt worse than right side. I?ve just treated with extra strength Tylenol and rest. Last night temperature was still 99, but sleep through the night. Today, February 1 still weak, ache all over, mild headache, and some pain on my left side body. I have not sought emergency treatment as if the date/time of report. I?m a healthcare worker taking today and tomorrow off work to recover.

Hard lump (golf ball size) to right of injection site, accompanied by circle red patch about 2" in diameter. Reporting this because I was the only one in our group that I know had this reaction. Pain is minimal, not more than expected but the readness and hard lump is what is unusual. I've travelled abroad and had a variety of vaccines. This is the first reaction of this type. Redness and hardness is subsiding by day 4 and now my arm just really itches in that spot. Reporting not because of concern but just to help with research.

Pt began complaining of itching and tingling. Made contact with patient and within a few minutes she developed a rash and difficulty breathing

1st day nausea, next day rapid heart rate, sore arm, headache, nausea 3rd day - sore arm, headache,nausea,chills 4th day - headache, chills and feeling hot, nausea,skin rash , itching, tired,aches 5th day - headache,chills and feeling hot, nausea,rash and uncontrollable itching, tired.

hives and rash on arm, patient was alarmed, went and hid in the kitchen, was concerned tablets wouldn't work so gave Benadryl 50mg

muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a spontaneous report via a Pfizer-sponsored program from a contactable nurse (reporting for herself). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), intramuscular in the left arm on 02Jan2021 at a single dose for COVID-19 immunization. Medical history was reported none. The patient's concomitant medications were not reported. The patient previously received the flu vaccine on unspecified date and experienced discomfort. On 02Jan2021, the patient experienced pain at injection site. On 03Jan2021, the patient experienced muscle aches and discomfort. The patient was scheduled for the second dose of the COVID-19 vaccine and reported that she took Aleve after she got the first vaccine and was wondering if she can take Aleve after the second one. She stated that it helped with the pain. She said that she was getting conflicting information and stated that she heard that there have been more symptoms associated with the second vaccine. She wanted to know if it was contraindicated for her to take the Aleve after getting the second dose. The patient described it as discomfort and stated that she gets it with the flu vaccine too. Aleve helped with the discomfort and the ache. She did not pre-medicate. She took it afterward. She stated that she took maybe 1-2 doses of the Aleve the next day and stated that by the end of the next day her pain was fine. The patient clarified pain was at the injection site and was achy. She said that she received the first vaccine on 02Jan2021 in the morning. She noticed the pain later in the day around midafternoon and said that it was gone by the next day. The outcome of the event pain at injection site was recovered on 03Jan2021 while outcome of muscle aches and discomfort was recovered on unspecified date in Jan2021.

Individual received the 1st dose of the Pfizer COVID vaccine on 12/ 22/20.On the first week of January 2021 she developed left neck and supraclavicular lymphadenopathy. CT scan on 1/13/21revealed multiple lymphadenopathy over the left supraclavicular area. Excisional biopsy of deep neck supraclavicular lymph nodes on 1/20/21. Surgical pathology revealed overall finding most consistent with a reactive lymphoid hyperplasia, etiology unknown. She received her 2nd Pfizer COVID vaccine on 1/12/21. She had slight redness/swelling of her left arm two to three days after vaccine. She developed red, raised itching rash on her trunk on 1/30/21. Rash continues as of today 2/5/21.

Soreness and swelling at site of injection 4 hrs after injection Chills one day after vaccine Joint pain one day after vaccine Fatigue one day after vaccine Foggy, light headed feeling one day after vaccine Headache and fatigue day 2 after vaccine

Dose 1 and 2 usual adverse events. Sore arm, achey, tired and crappy. But after dose 2 after 24 hours I began to notice itching. My back, neck, legs, arms. Begins once my zyrtec wears off around 7:30 pm I always take and antihistamine to keep my nose clear for better sleep. All nighttime meds are take at 8- 8:30 pm. Must take ativan to control anxiety and help get to sleep

Injection site pain started 6 hours after shot. 18 hrs after shot total body aches, fever, headache lasting 16 hrs.

its been 7 days now and am just getting sicker from then shot itching has increased and now have hematomas on my body. lungs fill heavy and headaches gotten more painful and i fell like my brain is not right. and diarrhea with pain in lower abdomen . I do not think i should be getting the second shot. I do not have a doctor and cant afford to go to er. I send you information of the first 5 days but do not have that report number.

Patient started complaining of tongue swelling, same as when she had an anaphylatic reaction to strawberries. Patient was given 1 epi pen at 11:07am in the left thigh at the clinic. EMS transport Patient is a 63 y/o F with h/o environmental allergies and asthma who presents to the ED via EMS for evaluation of an allergic rxn that began at 1030 today. Pt was at hospital and had just received her first COVID vaccine when she developed a facial rash and swelling to her tongue and throat. She also c/o dizziness. She was given Epi, Solumedrol, and Benadryl via EMS with improvement. Pt currently receives an allergy shot monthly for tx of her environmental allergies. She has never used an Epi pen previously. Pt denies fever.

I had pain at the injection site initially and it increased on day 2. Also on day 2, I saw a small rash after showering. The muscle pain has de erased, but the injection site is very tender and the rash has spread down my arm about 2-3 inches. Today, day 5, the rash is slightly itchy. On day 2, I had chills, body aches, joint pain and a headache. All symptoms were gone within 48 hours with the exception of the headache. The headache lasted until day 5.

My face started feeling very hot / feeling warm; my arms were looking mottled; first got hives under my neck on the left side and then it traveled to the tight side of my neck/ had hives on my arms legs neck chest and back; within 5 more minutes my neck was red / my face started getting red; This is a spontaneous report from a contactable Health Professional, the patient. A 63-year-old non-pregnant female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3242), via intramuscular route in the left arm on 22Jan2021 17:00 (at the age of 63-years) as a single dose for COVID-19 immunization. Medical history included Thyroid -Hashimoto's thyroiditis, Penicillin allergy, Brussels sprouts and avocados allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included levothyroxine and ibuprofen (ADVIL). The patient previously took erythromycin and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 22Jan2021 at 17:15, after approximately 10 minutes of receiving vaccination, the patient started feeling warm, she noticed her arms were looking mottled and she went to the nurse. She first got hives under her neck on the left side and then it traveled to the tight side of my neck. Within 5 more minutes her neck was red, and her face had started feeling very hot. Her face started getting red. The patient was taken to the emergency room and she had hives on her arms, legs, neck, chest, and back. The patient was treated for feeling very hot, arms mottled, hives, and neck and face red with intravenous (IV) Benadryl 50mg with Famotidine IV and saline solution IV. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event for feeling very hot, arms mottled, hives, and neck and face red were recovered in Jan2021; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events is possible . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I had a light presentation of hives. The locations of the hives were in the crease of my right arm (elbow area), torso (tummy area), top of foot and ankles.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: ELI283), via an unspecified route of administration on the left arm on 23Jan2021 11:45 at SINGLE DOSE for COVID-19 immunization. It was reported that the patient was allergic to Amoxicillin. The patient was not pregnant (including at the time of vaccination). Medical history and concomitant medications were not reported. On 23Jan2021 22:00, the patient had a light presentation of hives. The locations of the hives were in the crease of the right arm (elbow area), torso (tummy area), top of foot and ankles. The patient did not receive treatment for the event. The patient was not diagnosed with COVID-19 prior and not tested since vaccination. Outcome of the event was recovering.

burning sensation; severe blistering raised rash on right leg, arm, buttcheek and back; severe blistering raised rash on right leg, arm, buttcheek and back; Dermatitis; the rash/it is red; This is a spontaneous report from a contactable Consumer (patient). A 63-year-old female patient received bnt162b2 (lot number: EL3249, Expiry Date: May2021), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization. Medical history included Hiatal hernia, heartburn and stuff. The patient's concomitant medications was unspecified medication for heartburn and stuff. The patient previously took clindamycin and allergy. The patient received vaccine on 15Jan2021, started developing severe blistering raised rash on right leg, arm, buttcheek and back on Jan2021. The patient experienced rash, now raised and blistering. On 15Jan2021, legs butt cheeks on back right side of body (same side of body) burning sensation. Patient got a dermatitis on Jan2021. She don't know what dermatitis looks like but the rash she got, it like raised up and it is red and some of it is like blistered. Because she got like a blistering rash at first it was just a rash then it started kind of blistering. They have gotten worsened, they started Monday or Tuesday (Jan2021), the rash started but its got worse since then and spread. She just put some Calmoseptine on it. It is over the counter, it is almost like a diaper rash that she used on it. But she kind of got like the burning sensation too. Its an ointment. It is like a diaper rash ointment. She figured she would try that because she did an antibiotic ointment (Unspecified Ointment) and it didn't work at all. The outcome of the event burning sensation was unknown, other events was not recovered.

Arm a little sore below injection site. Mild start of a headache for two days but never kicked in. Weird taste in my mouth 2 hours after shot that only lasted 2 hours.

The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; The temperature that the Pharmacist recorded was not correct/transport the covid 19 vaccines had a temperature of 31 to 33 degrees F; improper technique; bruising after the first shot because of improper technique; felt hot at the injection site; swelling; tiredness/tired; arm pain; headache; chills; This is a spontaneous report from a contactable pharmacist (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot EJ1686, expiry date not reported), intramuscular on 02Jan2021 17:00 at a single dose in the left arm for COVID-19 immunization. Medical history included hypertension, known allergies to latex and has covid-19, all from unknown dates and unknown if ongoing. The patient was not pregnant at the time of the vaccination. Concomitant medications included hydrochlorothiazide, potassium chloride, and calcium citrate (CITRACAL). The patient had no other vaccine in four weeks. Patient stated that a cooler used to transport the covid 19 vaccines had a temperature of 31 to 33 degrees F and she was concerned about the vaccines on the bottom of the shipper that were next to the dry ice in the shipper (date unspecified). Patient wanted temperature excursion data for the covid 19 vaccine and stated in Jan2021 she felt hot at the injection site, swelling, tired, arm pain and had bruising after the first shot because of improper technique (02Jan2021 17:00). Patient reported on the first dose having only arm pain, chills, and tiredness, and headache in Jan2021. Patient also stated that the first dose was much better tolerated. Patient stated some of her pharmacist friends have had the same effects from the vaccine. Patient wanted to verify that the vaccine in the syringe is good for 6 hours and that she read Moderna is effective for 1 year and Pfizer is good for 6 to 12 months. She does not think her vaccination of covid 19 was valid because she thinks the temperature that the pharmacist recorded was not correct. Patient wanted to know if she should get tested to see if the vaccine worked. Patient stated that Pfizer is too complex and has too many pieces and states they need to give more information about how to use the thermal shipper. The patient had Covid test post vaccination as nasal swab on (BioReference COVID-19 Nasopharynx) on 26Jan2021 with results as pending. No treatments received felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache. The patient did recover from the events felt hot at the injection site, swelling, tired, arm pain, had bruising after the first shot, chills and headache on an unspecified date in Jan2021.

Pfizer BioNTech COVID-19 Vaccine EUA left armpit lymph node swelling injection site pain headache nausea joint pain

Symptoms: pruritic chest Intervention: VS stable. Monitored. Stayed an additional 15 minutes due to appointment at the hospital, total 30 min. Instructed patient to go to the nearest ED if s/sx worsens. No SOB noted. Denies pain. States may take Benadryl at home.

I washed my hair on Saturday. Had significant hair loss - HUGE amount of hair. I've lost 30 percent of the hair on my head. It continued to fall out and to have hair loss for one week. Saw doctor - She said the immune system was stressed and hair fell out. Dr. e-visit - Tuesday, the 9th.

Patient started with itching all over. Redness and hives on chest. "Itchy throat" with frequent clearing of throat observed. Bilateral breath sounds were clear and equal. No angioedema noted. Vital sings were monitored. Pulse was 98-99% on room air. Later felt a headache and felt jittery. Benadryl 50 mg PO was administered. Within 20 minutes of Benadryl symptoms improved. Prior to discharge the patient was no longer clearing her throat. Patient states she felt better. Husband reports chest and hive are basically gone. Patient remained alert and oriented x4 the entire visit. Reviewed to continue with over the counter Benadryl and take per directions on bottle. Husband reported he would stop and get Pepcid to take with Benadryl. Patient ambulates out of clinic without problems. 4:28 pm 161/88 89 16 97% 4:36 pm 149/82 79 17 99%. 4:43 pm 142/66 71 17 99%. 5:00 pm 124/ 83 72 15 98%.

Within in an hour of receiving the vaccine, under the injection about 2-3 inches below the site, the muscle group was sore. The next morning I was dizzy, lightheaded, mild headache, nausea, chills. It went all throughout the day. I just drank some clear liquids and ate some soup. When I woke up the next day about 36 hours after receiving the vaccine I had low energy, nauseous, and lightheaded . By that night my arm started feeling weird, it had a tinging feeling, I went to look at it the mirror and there was a red area and bumps but it was lower under the injection site. It seemed to get worse, swelling and more rash so I took Loratadine 10 MG (antihistamine). I went to bed and when I woke up this morning the rash was gone but the soreness is still there and the tinging feeling in my arm is still there. It feels like when your arm falls asleep. I tried to called my doctor but their phones are down and I will try reach back out this afternoon.

I had a shingles vaccine on November 30, 2020. On Dec 30, 2020 I had my first dose of Covid vaccine. On Jan 6, 2021 I went to the ER for severe abdominal pain, 2 days later broke out with rash and diagnosed with Shingles. I took steroid, Valtrex and Gabapentin. Rash on abd and around to lower back, left side. The rash was not bad but the nerve pain was horrible. 2nd dose was due Jan 22, 2021, I was advised to wait due to still having shingle pain. I was getting better, pain was subsiding so I got my 2nd dose on Feb 5, 2021. I experienced an increase in my shingle pain, from a 2 up to a 5, for about another week. It is still some pain, I am still on Gabapentin and Tylenol to keep the pain at about a constant 1-2 (Feb 18, 2021).

First vaccine shot - No adverse events. Second vaccine shot - on the next evening (02/18/21), I had a very slight fever lasting just a couple of hours. Later in the evening, I had swelling and pain under my left arm pit lymph node. The pain continues as of this writing. The pain is dull in nature and more sensitive to the touch.

Within 1.5 hours of vaccine #1: Eye pain (both), itching without visible rash (left buttock only), thumb pain, brief leg "heaviness" (both) and fatigue, brief RLQ pain, increased tinnitus. The next evening: low back and neck (bone?) pain while attempting to sleep, out of character to usual back pain. By day 3 post injection, left nose tingling similar to onset of cold sore, which included left side of mouth the next day. By 7 days post injection, entire mouth area felt tingly similar to Novocaine wearing off. This lasted 3 days. Now improved. (took B-12 p.o.) Other brief episodes of chest discomfort, gum irritation, and anxiety. Vaccine #2 scheduled for 2/19/2021

24 hours after vaccine, developed: Chills - unable to get warm Rash on left arm, middle, chest, stomach, and back One lymph node enlarged under left arm - size of a golf ball, lasted 2 days

Experienced Double Vision about 30 minutes after injection. Cleared within 20 minutes. After 36 hours: injection site tenderness, swelling, (no redness)

I developed a red area on my right arm to the front side of where the Pfizer vaccine was administered. The red area is about 2 inches in circumference, warm to the touch and itches.

I developed chills on Friday, February 19, 2021 in the afternoon. Chills continued through Saturday, February 20, 2021. Did not feel well on Sunday, February 22nd and today, February 22nd, I woke up with a nice dose of shingles on my face. Went to see the nurse practitioner at Dr office. Not sure if this is a coincidence or a result of the vaccine.

Developed a blister on upper left inner forearm after about 10 hours. It resolved over night. After 24 hours, developed several small blisters (some that ran into each other) on inside of lower left forearm. They itch and hurt a little. Also have a few blisters on inside of lower right forearm, back of left leg, a couple on chest and trunk.

Patient received 2nd dose of Pfizer COVID vaccine. Blanching, erythematous, somewhat serpiginous rash to L arm and hand with blister present on medial aspect of proximal forearm. Not pruritic, not painful. Area with blister is tender to the touch. Rash is not present on the L shoulder, R arm, or back. Denies fevers. 2nd dose of COVID vaccine to L arm last Thursday. The rash seems to originate from the vaccination site and does not extend upwards. The rash was noticed only today during an office visit. Patient has an intellectual disability, and very independent. always wears a long sleeve and her caregivers had not noticed it until today when rash extended down to her hands below the long sleeve.

Chills, 102°, headache, body aches, extreme fatigue and injection site pain Symptoms began within 45 minutes lasted 48 hrs , treated with Tylenol. Unable to get out of bed.

I had a minimally sore injection sight the morning I had the vaccine. As the day went on I began to feel joint pain in my back. Around 2:00pm I began to feel chills. Around 5:00pm I registered a temperature of 99.1. My usual temperature is 96.7. I then had trouble staying asleep, had intense joint pain in my back, hands, and feet, which I treated with Tylenol around 11:00pm. I experienced heavy night sweats where I woke up at 5:15 am being soaked. The symptoms I felt overnight felt just like what I had when I was sick with Covid 19 in December 2020. My temperature had returned to normal by 6:00 am.

(2/25/2021) PATIENT REPORTS TO OFF-SITE COVID-19 VACCINE CLINIC. PATIENT FILLS OUT VACCINE CHECKLIST AND IT IS NOTED THAT PATIENT HAS PREVIOUS ISSUES WITH FLU SHOT WITH A HISTORY OF TORUBLE BREATHING. TEACHING IS PROVIDED WITH PATIENT REGARDING POSSIBLE SIMILAR REACTIONS WITH COVID-19 VACCINE AND THAT SHE SHOULD STAY AT LEAST 30 MINUTES AFTER VACCINATION IF SHE WISHES TO PROCEED. PATIENT CONSENT TO PROCEED WITH COVID-19 VACCINATION. VACCINE IS GIVEN AT 1000 INTO RIGHT ARM AND PATIENT IS ASKED TO STAY FOR OBSERVATION. AT 1030 PATIENT REPORTS TO THIS NURSE ITCHING AND HIVES. PATIENT IS OBSERVED TO HAVE HIVES COVERING BILATERAL ARMS AND CHEST. PATIENT DENIES BREATHING TROUBLE AT THIS TIME. EMERGENCY REACTION KIT IS BROUGHT TO PATIENT?S TABLE. AT 1032 ON CALL PROVIDER IS NOTIFIED OF REACTION AND ORDERS ARE GIVEN FOR BENADRYL 50MG IM. THIS IS GIVEN AT 1034 RN INTO GUTEAL AND PATIENT IS OBSERVED AND VS OBTAINED. AT 1040 PATIENT STATES HER THROAT FEELS ?SCRATCHY? AND ?TIGHT.? IT IS RECOMMENDED TO PATIENT SHE SHOULD BE SEEN IN THE EMERGENCY ROOM. PATIENT AGREES TO THIS IF SHE IS ABLE TO DRIVE HERSELF. PATIENT IS FOLLOWED IN HER VEHICLE TO EMERGENCY ROOM FROM OFF-SITE CLINIC (APPROX. 8 BLOCKS). ON CALL PROVIDER IS NOTIFIED AND HOSPITAL EMERGENCY ROOM IS GIVEN REPORT FROM THIS NURSE. UPON ARRIVAL TO ER PATIENT IS SEEN PER MD. PATIENT REPORTS SYMPTOMS OF CHEST PRESSURE, DYSPNEA, LIGHT HEADEDNESS, ABDOMINAL PAIN, RASH, REDNESS, WARTHM AND ITCHING. PATIENT IS GIVEN 0.4 MG SUBCU ADRENALINE AND 40 MG PREDNISONE ORALLY. PATIENT IS OBSERVED IN EMERGENCY ROOM x 1 HOUR. PATIENT REPORTS SHE IS STARTING TO FEEL BETTER. PATIENT IS DISCHARGED TO AT 1206 FROM EMERGENCY ROOM.

general aching joint pain, headache, spine pain not muscle pain felt like back was broken started around midnight lasted untill late evening. left thigh pain like someone was doing a vein stripping. nausea no vomiting. Felt bad for 2 days. reddness on left arm not at shot site with left arm pain for 2 days. reddness in lt arm still there 02-26-2021.Red raised area warm no drainage.

got dizzy; felt queasy; Temp was lightly elevated; Sore injection site; Could not sleep, very uncomfortable.; Got hot and sweaty about 3 1/2 hours after shot.; Got hot and sweaty about 3 1/2 hours after shot.; administration_date=26Jan2021; other vaccine date = 26Jan2021; administration_date=26Jan2021; other vaccine date = 26Jan2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) via an unknown route of administration on left arm (L shoulder/Arm) on 26Jan2021 at 09:00 AM at the age of 63 years old at a single dose for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included RA (Rheumatoid arthritis), Penicillin allergy and covid-19 (The patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications included leflunomide (ARAVA) at 20mg, once a day, daily vitamins and mesalamine 1/day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Also reported administration date 26Jan2021; other vaccine date 26Jan2021. On 26Jan2021 09:00, the patient experienced sore injection site (shot was given very high on L shoulder/Arm). Felt like a sharp pain when given. Got hot and sweaty about 3 and an half hours after shot. Could not sleep, very uncomfortable. Next morning (on 27Jan2021), the patient was getting ready to eat breakfast and got dizzy and felt queasy. Temp was lightly elevated. Taking Tylenol to help control soreness. The patient assessed the events as non-serious. No treatment was received in response to the adverse event. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events administration_date=26Jan2021; other vaccine date = 26Jan2021 was unknown and patient was recovering from all other events. Information on the lot/batch number has been requested.

tingling and numbness on left side of mouth and face, beginning immediately after injection, and continuing intermittently for two days so far. Exacerbation of rash on right hand that usually occurs when exposed to wheat, beginning 24 hours after injection. Muscular pain in back beginning 12 hours after injection and subsiding 40 hours after injection.

Rash on lower left leg and foot and burning sensation on saying. Patient is affected by CRPS 2. Chills aches and pains and headache the latter lasted three days

Site: Pain at Injection Site-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Dose potentially administered too high but patient didnt bleed. Banaid placement described as one finger width below acrimion bone. Immediately \u2026 at the time of injection \u2026 shooting nerve pain radiating down the arm into fingers. Pain became a hot tingle over the next 15-30 minutes. Impaired right arm mobility and range of motion \u2026 shoulder pain with motion beyond a modest range. Three days later still experiencing some pain with certain arm motions \u2026 primarily raising arm above shoulder

tingling sensation left skull; fever 101.8; Mild left arm soreness; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiry date: 31May2021), via intramuscular route of administration in the left arm on 15Jan2021 10:05 at a single dose for COVID-19 immunization. Medical history included open cholecystectomy in 1990, hypertension, and sleep apnoea (CPAP). The patient's concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22 Dec2020 and experienced fever, nausea, vomiting, diarrhea, metallic taste in mouth, Loss of taste/smell, minimal soreness at the site of injection, strange sensation of tingling in her skull, chills, dry mouth, feels like she has no saliva, tongue felt a little bit too dry, extremely tired, thirst, and altered taste. The patient experienced mild left arm soreness on 15Jan2021 and fever 101.8 on 16Jan2021 23:00. Patient took ibuprofen 400mg and ondansetron (ZOFRAN) 4mg. The patient also experienced tingling sensation left skull continues as described. The patient had no cough, sore throat, stuffy or runny nose. She had no shortness of breath, no nausea vomiting or diarrhea, and no loss of taste/smell or metallic taste in mouth. The patient underwent lab tests and procedures which included body temp: 99.7 on 15Jan2021 18:00, 101.8 on 16Jan2021 11 PM, 99.5 on 16Jan20213 PM, 99.8 on 16Jan2021 10 PM, 99.5 on 17Jan2021 9:00, 99.8 on 17Jan2021 8 PM, 100 on 17Jan2021 10 PM, 99.4 on 18Jan2021 07:00, 99.7 on 19Jan2021 16:00, 98.6 on 20Jan2021 11 AM. Outcome of tingling sensation left skull was not recovered, of remaining events was unknown.

A little bit of soreness in arm injection was administered; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in eft arm on 14Jan2021 09:05 at a single dose for vaccination. There were no relevant medical history and concomitant medications. The patient previously received flu shot on Sep2020. The patient experienced a little soreness in arm injection was administered on 14Jan2021 and recovered completely from this event by the evening of 14Jan2021. She was feeling good. Described the event as very minor, minimal similar to what one might get with a flu or tetanus shot. Information on Lot/Batch has been requested.

Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.

Fever; joint & muscle pain; joint & muscle pain; Injection site - large red spot (about 4 inches in diameter); swollen; hot to touch; other vaccine same date dose number 6; This is a spontaneous report from a contactable healthcare professional (patient). This 63-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL3247) via an unspecified route of administration in the left arm on 29Jan2021 at 14:15 (at the age of 63-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to shellfish and allergy to eggs, both from unknown dates and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (lot number EL0142) in the left arm on 11Jan2021; codeine from an unknown date for an unknown indication and experienced allergy; celecoxib (CELEBREX) from an unknown date for an unknown indication and experienced allergy; and alendronate sodium (FOSAMAX) from an unknown date for an unknown indication and experienced allergy. The patient reported fever, joint and muscle pain 24 hours after the vaccine and stated it lasted about 18 hours. She also reported about the injection site that it was a large red spot (about 4 inches in diameter), it was swollen and hot to touch starting about 24 hours after vaccination. She reported 3 days later it was still red, swollen and hot to touch. The events were reported as non-serious and did not require hospitalization. No treatment was provided for the events. The clinical outcomes of fever, joint and muscle pain were recovered on 31Jan2021. The clinical outcomes of large red spot (about 4 inches in diameter), swollen, hot to touch were not recovered. The clinical outcome of other vaccine same date dose number 6 was unknown. It was also reported that since vaccination, the patient had not been tested for COVID-19.